510(k)s Final Decisions Rendered for July1996, THE ANSPACH EFFORT, INC
Bruce Chang
TEMPOROMANDIBULAR JOINT PROSTHESIS
THE ANSPACH EFFORT, INC. 510(k) NO: K954224
ATTN: WILLIAM E ANSPACH PHONE NO : 407-220-8855
4500 RIVERSIDE DRIVE SE DECISION MADE: 17-JUL-96
PALM BEACH GARDENS, FL 33410 510(k) STATEMENT
510(k)s Final Decisions Rendered for July1996
The 510(k) summaries have been added to this listing.
The 510(k) number will appear as the link, if that summary is
available
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUL-96 THROUGH 30-JUL-96
DEVICE: 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
3M CO. 510(k) NO: K962065
ATTN: AMY FOWLER PHONE NO : 612-736-1590
3M CENTER, BUILDING 260-2B-09 SE DECISION MADE: 18-JUL-96
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR
A & D ENGINEERING, INC. 510(k) NO: K960319
ATTN: JERRY WANG PHONE NO : 408-263-5333
1555 MC CANDLESS DR. SE DECISION MADE: 02-JUL-96
MILPITAS, CA 95035 510(k) STATEMENT
DEVICE: LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
A B ELEKTA INSTR 510(k) NO: K961639
ATTN: SVERKER GLANS PHONE NO : 011 46 84025400
BIRGER JARLSGATAN 53 SE DECISION MADE: 26-JUL-96
STOCKHOLM, 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST SUBMISSION FOR CEFOTETAN
AB BIODISK 510(k) NO: K961517
ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760
DAVAGEN 10 SE DECISION MADE: 05-JUL-96
S-171 36 510(k) STATEMENT
SOLNA,
DEVICE: ETEST SUBMISSION FOR AZITHROMYCIN
AB BIODISK 510(k) NO: K961519
ATTN: ANN BOLMSTROM PHONE NO : 46 8 7300760
DAVAGEN 10 SE DECISION MADE: 05-JUL-96
S-171 36 510(k) STATEMENT
SOLNA,
DEVICE: IMX RUBELLA IGG
ABBOTT LABORATORIES 510(k) NO: K951541
ATTN: JOANNE RUPPRECHT PHONE NO : 707-938-2567
ONE ABBOTT PARK ROAD SE DECISION MADE: 16-JUL-96
ABBOTT PARK, IL 60064-3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUPUNCTURE NEEDLE PACK
ACU-MED, INC. 510(k) NO: K960769
ATTN: JEUNG H CHOI, M.D. PHONE NO : 818-843-4489
2701 WEST ALAMEDA AVENUE SE DECISION MADE: 10-JUL-96
SUITE 301 510(k) STATEMENT
BURBANK, CA 91505
DEVICE: ACUFEX TAG BIOABSORBABLE ANCHORS
ACUFEX MICROSURGICAL, INC. 510(k) NO: K961555
ATTN: AMY WALTERS PHONE NO : 508-339-9700
130 FORBES BLVD. SE DECISION MADE: 10-JUL-96
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARUS AF ROD
ACUMED, INC. 510(k) NO: K962091
ATTN: SHARI L JEFFERS PHONE NO : 503-627-9957
10950 S.W. 5TH ST., SUITE 170 SE DECISION MADE: 24-JUL-96
BEAVERTON, OR 97005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CW-DISPOSABLE ACUPUNCTURE NEEDLE
ACUPUNCTURE SUPPLIES IMPORT CO., I510(k) NO: K962419
ATTN: LYNN H HSU PHONE NO : 310-860-7170
11306 E. 183RD ST. 202 SE DECISION MADE: 25-JUL-96
CERRITOS, CA 90701 510(k) STATEMENT
DEVICE: TAKI DISPOSABLE ACUPUNCTURE NEEDLE
ACUPUNCTURE SUPPLIES IMPORT CO., I510(k) NO: K962787
ATTN: LYNN H HSU PHONE NO : 310-860-7170
11306 E. 183RD STREET SE DECISION MADE: 26-JUL-96
SUITE 202 510(k) STATEMENT
CERRITOS, CA 90703
DEVICE: ADVANCED MICRO-OSMOMETER MODEL 3300
ADVANCED INSTRUMENTS, INC. 510(k) NO: K962056
ATTN: DOUGLAS GUERETTE PHONE NO : 617-320-9000
TWO TECHNOLOGY WAY SE DECISION MADE: 11-JUL-96
NORWOOD, MA 02062 510(k) STATEMENT
DEVICE: FORMULA IV ELECTRIC MOBILITY VEHICLE
AEROTEK 510(k) NO: K954378
ATTN: JANET OSBORNE PHONE NO : 613 623 9760
P.O. BOX 394 SE DECISION MADE: 25-JUL-96
RENFREW, ONTARIO, 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROTEL "TELELINK" ECG TELEPHONIC RECEIVING INTERFACE
AEROTEL LTD. 510(k) NO: K961362
ATTN: GEORGE MYERS PHONE NO : 201-438-2310
201 ROUTE 17 SE DECISION MADE: 10-JUL-96
RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLETTE INFANT INCUBATOR
AIR SHIELDS, INC. 510(k) NO: K960980
ATTN: MARCI L GOLDFINGER, M.S.B.M.PHONE NO : 215-675-5200
330 JACKSONVILLE RD. SE DECISION MADE: 30-JUL-96
HATBORO, PA 19040 510(k) STATEMENT
DEVICE: NITELIFE BI-LEVEL CPAP
AIRSEP CORP. 510(k) NO: K943207
ATTN: EDWARD E VRANA PHONE NO :
290 CREEKSIDE DRIVE SE DECISION MADE: 29-JUL-96
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: ECHO. AKHO
ALLIANCE MEDICAL, INC. 510(k) NO: K951976
ATTN: KARIM MENASSA PHONE NO :
3610 VALIQUETTE STREET SE DECISION MADE: 26-JUL-96
ST-LAURENT, QUEBEC, 510(k) STATEMENT
DEVICE: DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
ALM SURGICAL EQUIPMENT, INC. 510(k) NO: K961742
ATTN: SUSAN NIELSEN PHONE NO : 800-842-2555
1820 NORTH LEMON ST. SE DECISION MADE: 26-JUL-96
ANAHEIM, CA 92801-1009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAGER GEMINA WALL-MOUNTED WORKPLACE
ALM SURGICAL EQUIPMENT, INC. 510(k) NO: K961886
ATTN: SUSAN NIELSON PHONE NO : 800-842-2555
1820 NORTH LEMON ST. SE DECISION MADE: 30-JUL-96
ANAHEIM, CA 92801-1009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
AMERICAN BIOPRODUCTS COMPANY 510(k) NO: K961579
ATTN: ANDREW LOC B LE, PH.D. PHONE NO : 201-631-1200
5 CENTURY DRIVE SE DECISION MADE: 10-JUL-96
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA - VWF CONTROL [N]+[P] KIT
AMERICAN BIOPRODUCTS COMPANY 510(k) NO: K962674
ATTN: ANDREW LOC B. LE PHONE NO : 201-631-1200
5 CENTURY DRIVE SE DECISION MADE: 23-JUL-96
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPODERMIC JET INJECTION APPARATUS
AMERICAN JET INJECTOR, INC. 510(k) NO: K962017
ATTN: ROBERT W HARRINGTON PHONE NO : 215-362-4815
880 ORCHARD LANE SE DECISION MADE: 26-JUL-96
LANSDALE, PA 19446-4520 510(k) STATEMENT
DEVICE: NEOSONO 2000
AMERICAN MEDICAL & DENTAL CORP. 510(k) NO: K955088
ATTN: JEROME FARBER PHONE NO : 609-429-8297
1236 BRACE ROAD SE DECISION MADE: 10-JUL-96
BUILDING B 510(k) STATEMENT
CHERRY HILL, NJ 08034
DEVICE: AMMI MAGNI-GUARD
AMERICAN MEDICAL MFG., INC. 510(k) NO: K961454
ATTN: MIKE HOFTMAN PHONE NO : 818-701-7171
9410 DESOTO AVE., UNIT J SE DECISION MADE: 25-JUL-96
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSE SPRAY INFUSION SYSTEM
ANGIODYNAMICS, DIV. E-Z-EM, INC. 510(k) NO: K961763
ATTN: BRIAN KUNST PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 17-JUL-96
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: PEGASUS DENTAL ALLOY
APM-STERNGOLD 510(k) NO: K962302
ATTN: NICHOLAS J SAVARESE PHONE NO : 508-226-5660
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 18-JUL-96
ATTLEBORO, MA 02703 510(k) STATEMENT
DEVICE: STERNGOLD CF
APM-STERNGOLD 510(k) NO: K962303
ATTN: NICHOLAS J SAVARESE PHONE NO : 508-226-5660
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 18-JUL-96
ATTLEBORO, MA 02703 510(k) STATEMENT
DEVICE: STERNGOLD BIO-4
APM-STERNGOLD 510(k) NO: K962304
ATTN: NICHOLAS J SAVARESE PHONE NO : 508-226-5660
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 23-JUL-96
ATTLEBORO, MA 02703 510(k) STATEMENT
DEVICE: STERNGOLD U-CPF METAL ALLOY (1067800)
APM-STERNGOLD 510(k) NO: K962324
ATTN: PHONE NO :
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 24-JUL-96
ATTLEBORO, MA 02703-0967 510(k) STATEMENT
DEVICE: QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
APM-STERNGOLD 510(k) NO: K962325
ATTN: NICHOLAS J SAVARESE PHONE NO : 508-226-5660
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 24-JUL-96
ATTLEBORO, MA 02703 510(k) STATEMENT
DEVICE: STERNGOLD BIO-5 (1127210)
APM-STERNGOLD 510(k) NO: K962326
ATTN: NICHOLAS J SAVARESE PHONE NO : 508-226-5660
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 24-JUL-96
ATTLEBORO, MA 02703 510(k) STATEMENT
DEVICE: APPLIED BIOTECH SURESTEP DRUG SCREEN AMPHETAMINE TEST
APPLIED BIOTECH, INC. 510(k) NO: K960743
ATTN: CHAI BUNYAGIDJ PHONE NO :
10237 FLANDERS CT. SE DECISION MADE: 05-JUL-96
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: APPLIED BIOTECH SURESTEP DRUG SCREEN THC TEST
APPLIED BIOTECH, INC. 510(k) NO: K960744
ATTN: CHAI BUNYAGIDJ PHONE NO :
10237 FLANDERS CT. SE DECISION MADE: 09-JUL-96
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: SURESTEP DRUG SCREEN MORPHINE TEST
APPLIED BIOTECH, INC. 510(k) NO: K960745
ATTN: CHAI BUNYAGIDJ PHONE NO :
10237 FLANDERS CT. SE DECISION MADE: 08-JUL-96
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: SPECIMEN RETRIEVAL BAG
APPLIED MEDICAL RESOURCES 510(k) NO: K962395
ATTN: HOWARD V ROWE PHONE NO : 714-582-6120
26051 MERIT CIRCLE, #104 SE DECISION MADE: 05-JUL-96
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
ARROW INTL., INC. 510(k) NO: K961358
ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137
3000 BERNVILLE ROAD SE DECISION MADE: 02-JUL-96
READING, PA 19605 510(k) STATEMENT
DEVICE: A PORT DETACHED CATHETER SYSTEM CATALOG #1002
ARROW INTL., INC. 510(k) NO: K961583
ATTN: BRADLEY J ENEGREN PHONE NO : 508-660-1122
1600 PROVIDENCE HIGHWAY SE DECISION MADE: 18-JUL-96
WALPOLE, MA 02081 510(k) STATEMENT
DEVICE: LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG
#1037
ARROW INTL., INC. 510(k) NO: K961615
ATTN: BRADLEY J ENEGREN PHONE NO : 508-660-1122
1600 PROVIDENCE HIGHWAY SE DECISION MADE: 19-JUL-96
WALPOLE, MA 02081 510(k) STATEMENT
DEVICE: LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG
#1017
ARROW INTL., INC. 510(k) NO: K961652
ATTN: BRADLEY J ENEGREN PHONE NO : 508-660-1122
1600 PROVIDENCE HIGHWAY SE DECISION MADE: 19-JUL-96
WALPOLE, MA 02081 510(k) STATEMENT
DEVICE: ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
ARTHROCARE CORP. 510(k) NO: K961747
ATTN: CHERLY L SHEA PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 15-JUL-96
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL
970ARTHROCARE CORP. 510(k) NO: K962321
ATTN: CHERYL L SHEA PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 19-JUL-96
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
ARTHROCARE CORP. 510(k) NO: K962445
ATTN: CHERYL L SHEA PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 30-JUL-96
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 6500 ABC ELECTROSURGICAL UNIT
ASPEN LABORATORIES, INC. 510(k) NO: K955834
ATTN: CHARLES M HART PHONE NO : 303-699-7600
14603 EAST FREMONT AVENUE SE DECISION MADE: 11-JUL-96
ENGLEWOOD, CO 80112 510(k) STATEMENT
DEVICE: RIONET HEARING AID HB53-K
AUTHORIZED HEARING SYSTEMS, INC. 510(k) NO: K961907
ATTN: HENRY SMITH PHONE NO : 215-788-0330
806 BEAVER STREET SE DECISION MADE: 03-JUL-96
BRISTOL, PA 19007 510(k) STATEMENT
DEVICE: COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE
3 V
BAXTER HEALTHCARE CORP. 510(k) NO: K961703
ATTN: TAMIMA ITANI, PH.D. PHONE NO : 847-270-2577
ROUTE 120 & WILSON RD. SE DECISION MADE: 08-JUL-96
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEK-STIX U.T.I. SELF-TEST
BAYER CORP. 510(k) NO: K960888
ATTN: ROSANNE M SAVOL PHONE NO : 219-262-6929
1884 MILES AVE. SE DECISION MADE: 05-JUL-96
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1
SYST
BAYER CORP. 510(k) NO: K962355
ATTN: GABRIEL J MURACA, JR. PHONE NO : 914-631-8000
511 BENEDICT AVE. SE DECISION MADE: 12-JUL-96
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
BEHRING DIAGNOSTICS, INC. 510(k) NO: K962373
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 617-320-3023
151 UNIVERSITY AVENUE SE DECISION MADE: 11-JUL-96
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N CRP STANDARD SY
BEHRING DIAGNOSTICS, INC. 510(k) NO: K962406
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 617-320-3023
151 UNIVERSITY AVE. SE DECISION MADE: 16-JUL-96
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N/T PROTEIN CONTROL PY
BEHRING DIAGNOSTICS, INC. 510(k) NO: K962407
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 617-320-3023
151 UNIVERSITY AVE. SE DECISION MADE: 29-JUL-96
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N PROTEIN STANDARD PY
BEHRING DIAGNOSTICS, INC. 510(k) NO: K962410
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 617-320-3023
151 UNIVERSITY AVE. SE DECISION MADE: 16-JUL-96
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX CRP MONO REAGENT
BEHRING DIAGNOSTICS, INC. 510(k) NO: K962523
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 617-320-3023
151 UNIVERSITY AVE. SE DECISION MADE: 10-JUL-96
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS B12 CONTROLS
BEHRING DIAGNOSTICS, INC. 510(k) NO: K962694
ATTN: RUTH C FORSTADT PHONE NO : 617-320-3117
151 UNIVERSITY AVENUE SE DECISION MADE: 22-JUL-96
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDM
BIO-RAD LABORATORIES 510(k) NO: K960392
ATTN: JOHN W NELSON PHONE NO : 510-741-6015
4000 ALFRED NOBEL DRIVE SE DECISION MADE: 08-JUL-96
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRYTIME FOR BLADDER CONTROL SILENT
BIO-SYSTEMS RESEARCH 510(k) NO: K962416
ATTN: ARTHUR J SAFFIR PHONE NO : 503-636-3281
2057 SUMMIT DRIVE SE DECISION MADE: 22-JUL-96
LAKE OSWEGO, OR 97034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.510(k) NO: K954065
ATTN: LAURENCE A POTTER PHONE NO :
100 CASCADE DRIVE SE DECISION MADE: 10-JUL-96
ALLENTOWN, PA 18103-9562 510(k) STATEMENT
DEVICE: BG PATIENT EXAMINATION GLOVES, NON-STERILE
BIOGRAFIK (MALAYSIA) SDN BHD 510(k) NO: K961675
ATTN: A K WONG PHONE NO : 067 993 645
PT 3307 JALAN AM 1 SE DECISION MADE: 25-JUL-96
ARAB-MALAYSIAN INDUSTRIAL PARK 510(k) STATEMENT
NILAI, NEGERI SEMBILAN DARUL,
DEVICE: CHEMMATE(TM) CD43
BIOTEK SOLUTIONS, INC. 510(k) NO: K950148
ATTN: DEBORAH D HINMAN PHONE NO : 805-562-3888
120-B CREMONA DRIVE SE DECISION MADE: 02-JUL-96
SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
BOEHRINGER MANNHEIM CORPORATION 510(k) NO: K960800
ATTN: MARY KONING PHONE NO : 510-674-0667
2380A BISSO LANE SE DECISION MADE: 26-JUL-96
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS TSH ASSAY
BOEHRINGER MANNHEIM CORPORATION 510(k) NO: K961491
ATTN: BETSY SOARES-MADDOX PHONE NO : 510-674-0667
2400 BISSO LANE SE DECISION MADE: 22-JUL-96
P.O. BOX 4117 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, CA 94524-4117
DEVICE: ELECSYS PRECICONTROL TSH
BOEHRINGER MANNHEIM CORPORATION 510(k) NO: K962573
ATTN: MARY KONING PHONE NO : 510-674-0667
2400 BISSO LANE SE DECISION MADE: 22-JUL-96
CONCORD, CA 94524 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PRECICONTROL CARDIAC
BOEHRINGER MANNHEIM CORPORATION 510(k) NO: K962575
ATTN: MARY KONING PHONE NO : 510-674-0667
2400 BISSO LANE SE DECISION MADE: 22-JUL-96
CONCORD, CA 94524 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
BOSTON MEDICAL PRODUCTS, INC. 510(k) NO: K962688
ATTN: STUART K MONTGOMERY PHONE NO : 508-898-9300
117 FLANDERS RD. SE DECISION MADE: 25-JUL-96
WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEEDLE CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K961846
ATTN: LISA M QUAGLIA PHONE NO : 508-650-8267
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 15-JUL-96
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
C.R. BARD, INC. 510(k) NO: K960176
ATTN: ROBIN DRAGO PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 24-JUL-96
CANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
C.R. BARD, INC. 510(k) NO: K962077
ATTN: CAROL VIERLING PHONE NO : 770-784-6411
129 CONCORD RD., BLDG. 3 SE DECISION MADE: 30-JUL-96
BILLERICA, MA 01821-7031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNGLASSES (NON-PRESCRIPTION)
CANADD TRADING CO. 510(k) NO: K962775
ATTN: KIM HAE SOOK PHONE NO :
RM817, SOHYUN BLD., #175 SE DECISION MADE: 25-JUL-96
NAMSAN 2-DONG, JOONG-GU 510(k) STATEMENT
DAEGU,
DEVICE: RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
CARDIAC EVALUATION CENTER, INC. 510(k) NO: K954163
ATTN: JIM MCGUIRE PHONE NO : 414-545-6777
2063 SOUTH 116TH STREET SE DECISION MADE: 11-JUL-96
MILWAUKEE, WI 53227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARASYN HYDROGEL WOUND PRODUCTS
CARRINGTON LABORATORIES, INC. 510(k) NO: K961758
ATTN: DENNIS R SPARKMAN PHONE NO : 214-518-1300
2001 WALNUT HILL LANE SE DECISION MADE: 11-JUL-96
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYLORI IGG ELISA TEST SYSTEM
CARTER-WALLACE, INC. 510(k) NO: K961221
ATTN: WILLIAM L BOTELER PHONE NO :
1306F BAILES LANE SE DECISION MADE: 30-JUL-96
FREDERICK, MD 21701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER "FIRST
RE
CARTER-WALLACE, INC. 510(k) NO: K962183
ATTN: MAUREEN GARNER PHONE NO : 609-655-6345
HALF ACRE ROAD SE DECISION MADE: 10-JUL-96
P.O. BOX 1001 510(k) SUMMARY AVAILABLE FROM FDA
CRANBURY, NJ 08512-0181
DEVICE: DOCUMENT CARDIAC ASSAYED CONTROL
CASCO STANDARDS 510(k) NO: K961750
ATTN: CHRISTINE V BEACH PHONE NO : 207-878-7550
P.O BOX 970 SE DECISION MADE: 22-JUL-96
YARMOUTH, ME 04096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
CASCO STANDARDS 510(k) NO: K962630
ATTN: CHRISTINE V BEACH PHONE NO : 207-878-7550
P.O BOX 970 SE DECISION MADE: 22-JUL-96
YARMOUTH, ME 04096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMCARD GLUCOSE TEST
CHEM-ELEC, INC. 510(k) NO: K943503
ATTN: STEVEN H BERKEY PHONE NO : 219-834-4080
P.O. BOX 372 SE DECISION MADE: 23-JUL-96
NORTH WEBSTER, IN 46555 510(k) STATEMENT
DEVICE: SUNGLASSES
CHUNGSIN KAU OPTICAL MFY. CO. LTD.510(k) NO: K962436
ATTN: HOU KAU CHAN PHONE NO : 852 252 20621
BLOCK C, NO. 7,8/F, WAH TAT SE DECISION MADE: 02-JUL-96
IND BLDG., 8-10, WAS SING ST. 510(k) STATEMENT
KWAI CHUNG,
DEVICE: CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
CIBA-CORNING DIAGNOSTICS 510(k) NO: K961807
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH STREET SE DECISION MADE: 26-JUL-96
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTM REUSABLE PAK
CIRCUIT TREE MEDICAL, INC. 510(k) NO: K962430
ATTN: GLENN A DUNKI-JACOBS PHONE NO : 818-285-6644
9327 BLACKLEY ST. SE DECISION MADE: 23-JUL-96
TEMPLE CITY, CA 91780-3139 510(k) STATEMENT
DEVICE: CTM DISPOSABLE PAK
CIRCUIT TREE MEDICAL, INC. 510(k) NO: K962431
ATTN: GLENN A DUNKI-JACOBS PHONE NO : 818-285-6644
9327 BLACKLEY ST. SE DECISION MADE: 23-JUL-96
TEMPLE CITY, CA 91780-3139 510(k) STATEMENT
DEVICE: NON-GENERIC
CLASSIC ELEGANCE INTL., INC. 510(k) NO: K962310
ATTN: FOOK LOY SOTHAM PHONE NO : 909-594-8189
20639 LYCOMING ST., #B-9 SE DECISION MADE: 03-JUL-96
DIAMOND BAR, CA 91789 510(k) STATEMENT
DEVICE: PERKINS HAND-HELD APPLANATION TONOMETER
CLEMENT CLARKE INC. 510(k) NO: K961512
ATTN: MICHAEL J WILKINSON PHONE NO : 440 127 9414969
AIRMED HOUSE, EDINBURGH WAY SE DECISION MADE: 18-JUL-96
HARLOW, ESSEX CM20 2ED 510(k) STATEMENT
ENGLAND,
DEVICE: LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
CLINICAL CONTROLS, INC. 510(k) NO: K962432
ATTN: JAMES F GODFREY PHONE NO : 805-473-8277
750 FARROLL RD., SUITES B SE DECISION MADE: 05-JUL-96
GROVER BEACH, CA 93433 510(k) STATEMENT
DEVICE: G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE
CMC SENSE-IT, INC. 510(k) NO: K955815
ATTN: CLARK VIER PHONE NO : 800-828-9295
810 SOUTH 1ST STREET SE DECISION MADE: 23-JUL-96
SUITE 120 510(k) STATEMENT
HOPKINS, MN 55343
DEVICE: SMART SPOT
CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K961307
ATTN: IMRE FARKASH PHONE NO : 972 485 66233
MATAM HIGH TECH. CNTR. SE DECISION MADE: 01-JUL-96
HAIFA, 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
CONMED CORP. 510(k) NO: K961505
ATTN: IRA D DUESLER, JR. PHONE NO : 315-797-8375
P.O. BOX 3936 SE DECISION MADE: 18-JUL-96
ENGLEWOOD, CO 80155 510(k) STATEMENT
DEVICE: ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE
RADIOGRAPHIC/FLUOR
CONTINENTAL X-RAY CORP. 510(k) NO: K962140
ATTN: OSCAR KHUTORYANSKY PHONE NO : 708-345-3050
2000 SOUTH 25TH AVENUE SE DECISION MADE: 25-JUL-96
BROADVIEW, IL 60153 510(k) STATEMENT
DEVICE: MEDLITE/ERBIUM LASER SYSTEM
CONTINUUM BIOMEDICAL, INC. C/O CHA510(k) NO: K961748
ATTN: LAURIE A RIDENER PHONE NO : 510-356-2640
1000 BURNETT AVENUE, STE. 450 SE DECISION MADE: 26-JUL-96
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
CONTOUR MEDICAL TECHNOLOGY, INC. 510(k) NO: K960329
ATTN: JOSH TRANTUM PHONE NO : 615-793-9700
144 BAIN ST. SE DECISION MADE: 02-JUL-96
LAVERGNE, TN 37086 510(k) STATEMENT
DEVICE: EPIVIEW
CONVATEC, DIV. OF E.R. SQUIBB & SO510(k) NO: K961319
ATTN: ADRENNE MCNALLY PHONE NO : 908-281-2630
100 HEADQUARTERS PARK DRIVE SE DECISION MADE: 08-JUL-96
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET
TUBE
CONVATEC, DIV. OF E.R. SQUIBB & SO510(k) NO: K962604
ATTN: GEORGE J PRENDERGAST PHONE NO : 908-281-2682
100 HEADQUARTERS PARK DRIVE SE DECISION MADE: 18-JUL-96
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBCUTANEOUS URINARY DIVERSON STENT SET
COOK UROLOGICAL, INC. 510(k) NO: K961371
ATTN: TAMMY BACON PHONE NO :
1100 WEST MORGAN ST. SE DECISION MADE: 24-JUL-96
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRCLE NEPHROSTOMY CATHETER SET
COOK UROLOGICAL, INC. 510(k) NO: K961933
ATTN: RICK LYKINS PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 18-JUL-96
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
COULTER CORP. 510(k) NO: K961278
ATTN: MARION S GAIDE PHONE NO :
11800 SW 147 AVENUE SE DECISION MADE: 22-JUL-96
MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM
CRYSTAL MEDICAL TECHNOLOGY 510(k) NO: K954432
ATTN: CLINT FOLSOM PHONE NO : 205-975-9770
1075 13TH STREET SOUTH SE DECISION MADE: 24-JUL-96
BIRMINGHAM, AL 35294-4440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: (BRAND NAME) SUNGLASS FRAMES
CUSTOM OPTICAL FRAMES, INC. 510(k) NO: K962478
ATTN: MARC H AST PHONE NO : 301-816-9100
11611 OLD GEORGETOWN RD. SE DECISION MADE: 25-JUL-96
ROCKVILLE, MD 20852 510(k) STATEMENT
DEVICE: DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
DAKO CORP. 510(k) NO: K951965
ATTN: KIM M KOSAI PHONE NO : 805-566-6655
6392 VIA REAL SE DECISION MADE: 05-JUL-96
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL,
(HELPER/INDU
DAKO CORP. 510(k) NO: K961701
ATTN: GRETCHEN M MURRAY, PH.D., RAPHONE NO : 805-566-6655
6392 VIA REAL SE DECISION MADE: 16-JUL-96
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DALE GASTROSTOMY TUBE HOLDER
DALE MEDICAL PRODUCTS, INC. 510(k) NO: K961693
ATTN: EGIDIA M VERGANO PHONE NO : 415-941-4594
7 CROSS STREET SE DECISION MADE: 30-JUL-96
PLAIMVILLE, MA 02762-0556 510(k) STATEMENT
DEVICE: DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
DATA MEDICAL ASSOCIATES, INC. 510(k) NO: K961919
ATTN: C.H. MORRIS PHONE NO : 817-640-0965
845 AVENUE "G" EAST SE DECISION MADE: 01-JUL-96
ARLINGTON, TX 76011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
DEBUSK TECHNOLOGY CORP. 510(k) NO: K962290
ATTN: CAMILLE MATLOCK PHONE NO : 423-938-7828
200 DEBUSK LANE SE DECISION MADE: 03-JUL-96
POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-57 VIDEO IMAGING SYSTEM
DEL MEDICAL SYSTEMS CORPORATION 510(k) NO: K962024
ATTN: KARL J WEYDIG PHONE NO : 914-686-3600
ONE COMMERCE PARK SE DECISION MADE: 09-JUL-96
VALHALLA, NY 10595 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF CURE BONDING AGENT
DENT ZAR, INC. 510(k) NO: K962277
ATTN: EUGENE ZAROTSKY PHONE NO : 800-444-1241
19643 TRULL BROOK DRIVE SE DECISION MADE: 03-JUL-96
TARZANA, CA 91356 510(k) STATEMENT
DEVICE: MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
DENTATUS USA, LTD. 510(k) NO: K961704
ATTN: STEPHEN B RUBINSKY PHONE NO : 212-481-1010
192 LEXINGTON AVE. SE DECISION MADE: 26-JUL-96
SUITE 901 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10016
DEVICE: PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
DENTSPLY INTL. 510(k) NO: K962348
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 18-JUL-96
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY ENDURANCE CALCAR HIP PROSTHESIS
DEPUY, INC. 510(k) NO: K961619
ATTN: CHERLY HASTINGS PHONE NO : 219-372-7165
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 12-JUL-96
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEC STERILE GAUZE SPONGE
DERIVADAS DEGASA S.A. DE C.V. 510(k) NO: K961773
ATTN: PATRICK J LAMB PHONE NO : 813-942-3908
40178 U.S. 19 NORTH SE DECISION MADE: 29-JUL-96
TARPON SPRINGS, FL 34689 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
DEVON INDUSTRIES, INC. 510(k) NO: K961993
ATTN: GEORGE AUSTRIA PHONE NO : 818-709-6880
9530 DESOTO AVENUE SE DECISION MADE: 03-JUL-96
CHATSWORTH, CA 91311-5084 510(k) STATEMENT
DEVICE: URIC ACID-SL ASSAY CATALOGUE NO. 237-60
DIAGNOSTIC CHEMICALS LIMITED 510(k) NO: K961586
ATTN: KAREN CALLBECK PHONE NO : 902 566 1396
WEST ROYALTY INDUSTRIAL PARK, SE DECISION MADE: 23-JUL-96
CHARLOTTETOWN, P.E.I., 510(k) STATEMENT
DEVICE: ACETAMINOPHEN SERUM TOX EIA ASSAY
DIAGNOSTIC REAGENTS, INC. 510(k) NO: K961373
ATTN: YUH-GENG TSAY PHONE NO : 408-738-8788
601 CALIFORNIA AVE. SE DECISION MADE: 08-JUL-96
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: VALPROIC ACID EIA TEST
DIAGNOSTIC REAGENTS, INC. 510(k) NO: K961988
ATTN: YUG-GENG TSAY, PH.D. PHONE NO : 408-738-8788
601 CALIFORNIA AVE. SE DECISION MADE: 16-JUL-96
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: MEDSHIELD/AEROCHAMBER
DIEMOLDING CORP. 510(k) NO: K961455
ATTN: JEAN WALLACE PHONE NO : 315-697-2221
125 RASBACH STREET SE DECISION MADE: 25-JUL-96
CANASTOTA, NY 13032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FACTPLUS ONE STEP PREGNANCY TEST
DIRECT ACCESS DIAGNOSTICS 510(k) NO: K962521
ATTN: MARYLOU PANICO PHONE NO : 908-218-7560
440 RT. 22 EAST SE DECISION MADE: 29-JUL-96
BRIDGEWATER, NJ 08807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MLX MICROTITER PLATE LUMINOMETER
DYNATECH LABORATORIES, INC. 510(k) NO: K962265
ATTN: LARRY POOL PHONE NO : 703-803-1248
14340 SULLYFIELD CIRCLE SE DECISION MADE: 25-JUL-96
CHANTILLY, VA 22021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT
IMMUNOFL
E.I. DU PONT DE NEMOURS AND CO., I510(k) NO: K951851
ATTN: JAMES E KELLER PHONE NO : 302-451-0274
BUILDING 500, MAILBOX 514 SE DECISION MADE: 24-JUL-96
P.O. BOX 6101 510(k) STATEMENT
NEWARK, DE 19714-6101
DEVICE: KODAK MN-R 2000 CASSETTE
EASTMAN KODAK COMPANY 510(k) NO: K961453
ATTN: HENRY J PINK PHONE NO : 716-722-5564
1669 LAKE AVENUE SE DECISION MADE: 25-JUL-96
ROCHESTER, NY 14650 510(k) STATEMENT
DEVICE: ECOGEL 100 ULTRASOUND GEL
ECO-MED PHARMACEUTICALS INC. 510(k) NO: K961757
ATTN: PAUL L HOOEY PHONE NO : 905 564 6633
6155 TOMKEN RD., #13 SE DECISION MADE: 25-JUL-96
MISSISSAUGA, ONTARIO, 510(k) STATEMENT
DEVICE: SELECT/SP
ELSCINT, INC. 510(k) NO: K961464
ATTN: THOMAS J SPACKMAN, M.D., F.APHONE NO : 201-342-2020
505 MAIN STREET SE DECISION MADE: 03-JUL-96
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
HACKENSACK, NJ 07601
DEVICE: SENTINEL LIPASE LIQUID MODEL 17.401B
EQUAL DIAGNOSTICS 510(k) NO: K961179
ATTN: BRENDA Y KAN PHONE NO :
115 SUMMIT DR. SE DECISION MADE: 19-JUL-96
EXTON, PA 19341 510(k) STATEMENT
DEVICE: CERAMCO CROWNS AND BRIDGES
ERIC S. SMALL, DDS 510(k) NO: K961720
ATTN: JOHN N POLITIS PHONE NO : 213-630-8800
865 S. FIGUEROA ST., SE DECISION MADE: 18-JUL-96
SUITE 1388 510(k) STATEMENT
LOS ANGELES,, CA 90017
DEVICE: ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
ETHICON ENDO-SURGERY, INC. 510(k) NO: K961264
ATTN: LORRI J CHARVEZ PHONE NO : 513-483-3513
4545 CREEK RD. SE DECISION MADE: 19-JUL-96
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
EVENFLO COMPANY, INC. 510(k) NO: K960726
ATTN: DONALD E SEGAL PHONE NO :
1333 NEW HAMPSHIRE AVE., N.W. SE DECISION MADE: 22-JUL-96
SUITE 400 510(k) STATEMENT
WASHINGTON, DC 20036
DEVICE: RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
EXPERTECH ASSOCIATES, INC. 510(k) NO: K962532
ATTN: DAVID M LINK PHONE NO : 508-371-0066
100 MAIN STREET SE DECISION MADE: 25-JUL-96
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: READY-SET PUNCTAL PLUGS
FCI OPHTHALMICS, INC. 510(k) NO: K961909
ATTN: ANNE BOHSACK PHONE NO : 617-837-4416
P.O. BOX 465 SE DECISION MADE: 25-JUL-96
76 PROSPECT ST. 510(k) STATEMENT
MARSHFIELD HILLS, MA 02051
DEVICE: QUICKELS QS 200 SYSTEM
FERGUSON MEDICAL 510(k) NO: K954772
ATTN: FRANK FERGUSON PHONE NO : 916-342-4133
3407 BAY AVE. SE DECISION MADE: 11-JUL-96
CHICO, CA 95973 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKELS QS 100 SYSTEM
FERGUSON MEDICAL 510(k) NO: K954773
ATTN: FRANK FERGUSON PHONE NO : 916-342-4133
3407 BAY AVE. SE DECISION MADE: 11-JUL-96
CHICO, CA 95973 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS BLOOD TEMPERATURE MONITOR
FRESENIUS USA, INC. 510(k) NO: K941460
ATTN: TOM FOLDEN PHONE NO : 510-295-0200
2637 SHADELANDS DRIVE SE DECISION MADE: 03-JUL-96
WALNUT CREEK, CA 94598 510(k) STATEMENT
DEVICE: CARDIMAX MODEL FX-2111
FUKUDA DENSHI AMERICA CORPORATION 510(k) NO: K955416
ATTN: DAVID J GERAGHTY PHONE NO : 206-881-7737
7102-A 180TH AVENUE SE DECISION MADE: 15-JUL-96
NE A-101 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98052
DEVICE: SAFETY RELEASE MODULE
G & H WIRE CO. 510(k) NO: K961754
ATTN: MICHAEL JAHNS PHONE NO : 317-882-0993
1791 INDUSTRIAL DR. SE DECISION MADE: 10-JUL-96
GREENWOOD, IN 46142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNGLASSES, GAUDI SUN LINE
GAUDI SPA 510(k) NO: K962636
ATTN: CALVIN HOWELL PHONE NO : 407-365-2505
162 E. BROADWAY ST. SE DECISION MADE: 25-JUL-96
OVIEDO, FL 32765 510(k) STATEMENT
DEVICE: FUJI IX GP
GC AMERICA, INC. 510(k) NO: K961448
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 W. 127TH STREET SE DECISION MADE: 08-JUL-96
CHICAGO, IL 60658 510(k) STATEMENT
DEVICE: ADVANTAGE WINDOWS WITH FUNCTOOL OPTION
GE MEDICAL SYSTEMS 510(k) NO: K960265
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414 SE DECISION MADE: 03-JUL-96
W-709 510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53201
DEVICE: GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE),
WHI
GLOBAL MEDICAL PRODS INC. 510(k) NO: K961324
ATTN: PETER CLARK PHONE NO :
244 MAIN STREET SOUTH SE DECISION MADE: 02-JUL-96
WOODBURY, CT 06798-0505 510(k) STATEMENT
DEVICE: LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
GRAHAM-FIELD, INC. 510(k) NO: K961857
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 03-JUL-96
SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MEDI-TRACE DEFIB PADS
GRAPHIC CONTROLS CORP. 510(k) NO: K955597
ATTN: SUSAN KRASNY PHONE NO : 716-849-6301
189 VAN RENSSELAER STREET SE DECISION MADE: 09-JUL-96
P.O. BOX 1271 510(k) STATEMENT
BUAFFLO, NY 14240-1271
DEVICE: MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR
PHYSIO
GRAPHIC CONTROLS CORP. 510(k) NO: K955828
ATTN: KATHLEEN SELOVER PHONE NO : 716-849-6301
189 VAN RENSSELAER STREET SE DECISION MADE: 25-JUL-96
P.O. BOX 1271 510(k) STATEMENT
BUAFFLO, NY 14240-1271
DEVICE: PURITAN FOAM TIP SWAB MODEL 2197
HARDWOOD PRODUCTS CO. 510(k) NO: K961934
ATTN: WILLIAM M YOUNG PHONE NO : 207-876-3311
P.O. BOX 149, SCHOOL ST. SE DECISION MADE: 09-JUL-96
GUILFORD, ME 04443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CVM TRANSPORT
HARDY DIAGNOSTICS 510(k) NO: K955451
ATTN: MELISSA M TAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 22-JUL-96
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: SUBLIMINATOR
HEALEX PRODUCTS, INC. 510(k) NO: K961457
ATTN: MILTON HODOSH PHONE NO : 401-781-3223
243 ELMWOOD AVENUE SE DECISION MADE: 18-JUL-96
PROVIDENCE, RI 02907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
HEALTHSCAN PRODUCTS, INC. 510(k) NO: K961077
ATTN: LAUREN R ZIEGLER PHONE NO : 201-857-3514
908 POMPTON AVE SE DECISION MADE: 15-JUL-96
CEDAR GROVE, NJ 07009-1292 510(k) STATEMENT
DEVICE: HANC NETWORK
HEALTHTECH SERVICES CORP 510(k) NO: K952979
ATTN: MICHAEL J GLYNN PHONE NO : 708-205-2530
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 25-JUL-96
WSHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K961339
ATTN: RICHARD T KOO PHONE NO : 408-748-9585
2080A WALSH AVE. SE DECISION MADE: 03-JUL-96
SANTA CLARA, CA 95050 510(k) STATEMENT
DEVICE: EUB-905
HITACHI MEDICAL CORPORATION OF AME510(k) NO: K962308
ATTN: CHARLES F HOTTINGER, PH.D. PHONE NO : 408-741-1006
660 WHITE PLAINS ROAD SE DECISION MADE: 17-JUL-96
TARRYTOWN, NY 10591-5107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRIS
HITACHI MEDICAL SYSTEMS AMERICA 510(k) NO: K961876
ATTN: JAMES J ROGERS PHONE NO : 216-425-1313
1963 CASE PARKWAY SE DECISION MADE: 25-JUL-96
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
HOWMEDICA 510(k) NO: K954559
ATTN: MARGARET F CROWE PHONE NO : 201-507-7431
359 VETERANS BOULEVARD SE DECISION MADE: 12-JUL-96
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON INSET PATELLA WITH CENTRAL PEG
HOWMEDICA 510(k) NO: K961482
ATTN: MARGARET F CROWE PHONE NO : 201-507-7431
359 VETERANS BLVD. SE DECISION MADE: 05-JUL-96
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON ALL POLYETHYLENE PATELLA II
HOWMEDICA 510(k) NO: K961483
ATTN: MARGARET F CROWE PHONE NO : 201-507-7431
359 VETERANS BLVD. SE DECISION MADE: 09-JUL-96
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
IDEAS FOR MEDICINE, INC. 510(k) NO: K954713
ATTN: ELIZABETH M PAUL PHONE NO :
12167 49TH STREET NORTH SE DECISION MADE: 24-JUL-96
P.O. BOX 17327 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 34622
DEVICE: SHARED VISION(PART NUMBER SV 0015)
IMAGELABS INCORPORATED 510(k) NO: K961753
ATTN: LISA BERGEN PHONE NO : 617-271-1300
19A CROSBY DRIVE, SUITE 300 SE DECISION MADE: 25-JUL-96
BEDFORD, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSPAN HYSTEROSCOPE SHEATH
IMAGYN MEDICAL, INC. 510(k) NO: K961506
ATTN: DEBRA A RINDERER PHONE NO : 714-362-2500
27651 LA PAZ RD. SE DECISION MADE: 03-JUL-96
LAGUNA NIGUEL, CA 92677-3917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
IN-LINE DIAGNOSTICS CORP. 510(k) NO: K953875
ATTN: JAMES M CONIS PHONE NO :
4646 S. 1500 W., SUITE 160 SE DECISION MADE: 23-JUL-96
OGDEN, UT 84405-3989 510(k) STATEMENT
DEVICE: INCSTAR CYTOMEGALOVIRUS IGG "FAST" ELISA ASSAY
INCSTAR CORP. 510(k) NO: K955360
ATTN: MART FRICK PHONE NO : 612-439-9710
1990 INDUSTRIAL BLVD. SE DECISION MADE: 22-JUL-96
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
INCSTAR CORP. 510(k) NO: K955361
ATTN: MARK FRICK PHONE NO : 612-439-9710
1990 INDUSTRIAL BLVD. SE DECISION MADE: 22-JUL-96
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: INCSTAR HSV I/II IGG "FAST" ELISA ASSAY
INCSTAR CORP. 510(k) NO: K955362
ATTN: MARY FRICK PHONE NO : 612-439-9710
1990 INDUSTRIAL BLVD. SE DECISION MADE: 24-JUL-96
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: INCSTAR HSZ I/II IGG ELISA ASSAY
INCSTAR CORP. 510(k) NO: K955363
ATTN: MARY FRICK PHONE NO : 612-439-9710
1990 INDUSTRIAL BLVD. SE DECISION MADE: 24-JUL-96
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: INNERDYNE STEP TROCAR EXPANDABLE PORT, "ONESTEP"
INNERDYNE, INC. 510(k) NO: K961940
ATTN: RICK GAYKOWSKI PHONE NO : 800-669-4869
5060 WEST AMELIA EARHART DR. SE DECISION MADE: 10-JUL-96
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STS SHIELD WITH MASK
INNOVATIVE OUTSOURCING SOLUTIONS 510(k) NO: K961402
ATTN: LAWRENCE A RUCKI PHONE NO : 508-251-8240
51 MIDDLESEX ST. SE DECISION MADE: 12-JUL-96
NORTH CHELMSFORD, MA 01863 510(k) STATEMENT
DEVICE: SORBCEL ALGINATE/CMC WOUND DRESSING
INNOVATIVE TECHNOLOGIES LTD. 510(k) NO: K962421
ATTN: PRISCILLA WHITEHEAD PHONE NO : 011 441 606863500
ROAD THREE, SE DECISION MADE: 11-JUL-96
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE,
DEVICE: NOVA LITE ANCA
INOVA DIAGNOSTICS, INC. 510(k) NO: K961340
ATTN: BRYS C MYERS PHONE NO :
10451 ROSELLE STREET SE DECISION MADE: 10-JUL-96
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: QUANTA LITE ENA 6 ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K961913
ATTN: BRYS C MYERS PHONE NO : 619-455-9495
10451 ROSELLE STREET SE DECISION MADE: 10-JUL-96
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
INSTRUMENT MAKAR, INC. 510(k) NO: K960555
ATTN: ANDREW P ABOOD PHONE NO :
C/O ABOOD,ABOOD & RHEAUME,P.C. SE DECISION MADE: 09-JUL-96
603 S. WASHINGTON AVE. 510(k) STATEMENT
LANSING, MI 48933-2337
DEVICE: NATURAL HIP SYSTEM
INTERMEDICS ORTHOPEDICS, INC. 510(k) NO: K960258
ATTN: JACQUELYN HUGHES PHONE NO : 512-432-9900
9900 SPECTRUM DR. SE DECISION MADE: 12-JUL-96
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APR FULLY TEXTURED HIP STEM
INTERMEDICS ORTHOPEDICS, INC. 510(k) NO: K961589
ATTN: SHAVAWN PARDUHN PHONE NO : 512-432-9360
9900 SPECTRUM DR. SE DECISION MADE: 09-JUL-96
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
INTERMEDICS ORTHOPEDICS, INC. 510(k) NO: K961727
ATTN: SAM MIRZA PHONE NO : 512-432-9751
9900 SPECTRUM DR. SE DECISION MADE: 19-JUL-96
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL HIP SYSTEM - DRG HIP STEM
INTERMEDICS ORTHOPEDICS, INC. 510(k) NO: K961799
ATTN: SAM MIRZA PHONE NO : 512-432-9751
9900 SPECTRUM DR. SE DECISION MADE: 15-JUL-96
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGATRON OPHTHALMIC SURGICAL SYSTEM
INTL. OPHTHALMIC INDUSTRIES CORPOR510(k) NO: K961658
ATTN: HILLARD W WELCH PHONE NO : 508-771-6777
344 ANNABELLE POINT RD. SE DECISION MADE: 23-JUL-96
P.O. BOX 628 510(k) STATEMENT
CENTERVILLE, MA 02632
DEVICE: OMNI-TRAK PATIENT MONITORING SYSTEM
INVIVO RESEARCH, INC. 510(k) NO: K955045
ATTN: FRANCIS X CASEY PHONE NO :
12601 RESEARCH PARKWAY SE DECISION MADE: 11-JUL-96
ORLANDO, FL 32826 510(k) STATEMENT
DEVICE: DIOPEXY PROBE
IRIS MEDICAL INSTRUMENTS, INC. 510(k) NO: K960522
ATTN: THEODORE A BOUTACOFF PHONE NO : 415-962-8100
340 PIONEER WAY SE DECISION MADE: 19-JUL-96
MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
J-TECH, INC. 510(k) NO: K954737
ATTN: TRACY LIVINGSTON PHONE NO :
50 WEST CANYON RD. SE DECISION MADE: 03-JUL-96
ALPINE, UT 84004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
JOHNSON & JOHNSON MEDICAL, INC. 510(k) NO: K961632
ATTN: MARGARET L MARSH PHONE NO : 817-784-4897
P.O. BOX 90130 SE DECISION MADE: 03-JUL-96
ARLINGTON, TX 76004-3130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
JOHNSON & JOHNSON PROFESSIONALS, I510(k) NO: K961685
ATTN: JOHN D FERROS PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 10-JUL-96
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA SCALP BLOOD COLLECTION SET
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K954982
ATTN: MARIKA ANDERSON PHONE NO :
600 CORPORATE POINTE SE DECISION MADE: 17-JUL-96
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ TWIN TRANSILLUMINATOR
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K962032
ATTN: MARIKA ANDERSON PHONE NO : 310-558-1500
600 CORPORATE POINTE SE DECISION MADE: 05-JUL-96
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KILTEX PROBE COVER
KILTEX CORPORATION 510(k) NO: K961029
ATTN: TIMOTHY J KILLIAN PHONE NO : 330-644-6746
2064 KILLIAN RD SE DECISION MADE: 25-JUL-96
AKRON, OH 44312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAO HAND SURGERY SET
KINETIKOS MEDICAL, INC. 510(k) NO: K960539
ATTN: MARK G URBANSKI PHONE NO :
3950 SORRENTO VALLEY BLVD. SE DECISION MADE: 23-JUL-96
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBTALAR MBA SYSTEM
KINETIKOS MEDICAL, INC. 510(k) NO: K960692
ATTN: MARK G URBANSKI PHONE NO : 619-558-2233
3950 SORRENTO VALLEY BLVD., SE DECISION MADE: 23-JUL-96
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFE IMAGING SYSTEMS LIS 6000 A
LIFE IMAGING SYSTEM, INC. 510(k) NO: K961403
ATTN: RICHARD DERMAN PHONE NO : 215-364-6927
306A WEATHERVANE SE DECISION MADE: 03-JUL-96
OFFICE COMMONS 510(k) SUMMARY AVAILABLE FROM FDA
RICHBORO, PA 18954
DEVICE: TRUSTEX FLAVOR CONDON IN COLORS
LINE ONE LABORATORIES & TRADING CO510(k) NO: K946103
ATTN: BUDIMAN LEE PHONE NO : 213-222-9848
P.O. BOX 861941 SE DECISION MADE: 15-JUL-96
LOS ANGELES, CA 90086 510(k) STATEMENT
DEVICE: DICOMNET
LOCKHEED MARTIN COMMUNICATIONS SYS510(k) NO: K961451
ATTN: VINCENT J NAPOLEON PHONE NO : 609-338-3331
1 FEDERAL ST. SE DECISION MADE: 03-JUL-96
CAMDEN, NJ 08103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX, RAMSES, SHEIK
LONDON INTERNATIONAL U.S. HOLDINGS510(k) NO: K952415
ATTN: PHYLISS M BARBER PHONE NO :
1819 MAIN STREET SE DECISION MADE: 15-JUL-96
SUITE 800 510(k) STATEMENT
SARASOTA, FL 34236
DEVICE: LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
LONDON INTERNATIONAL U.S. HOLDINGS510(k) NO: K953813
ATTN: PHYLISS M BARBER PHONE NO : 941-365-1600
1819 MAIN STREET, SUITE 800 SE DECISION MADE: 22-JUL-96
SARASOTA, FL 34236 510(k) STATEMENT
DEVICE: LOUISVILLE LABS OXYGEN HEAD TENT
LOUISVILLE LABORATORIES, INC. 510(k) NO: K955535
ATTN: DAVID PHELPS PHONE NO : 502-634-5900
2400 CRITTENDEN DR. SE DECISION MADE: 01-JUL-96
LOUISVILLE, KY 40217 510(k) STATEMENT
DEVICE: CONTROL SYRINGE
LOUISVILLE LABORATORIES, INC. 510(k) NO: K960882
ATTN: DAVID PHELPS PHONE NO : 502-634-5900
2400 CRITTENDEN DR. SE DECISION MADE: 08-JUL-96
LOUISVILLE, KY 40217 510(k) STATEMENT
DEVICE: AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
LUMEX DIV., LUMEX, INC. 510(k) NO: K962123
ATTN: JOE Z ANETTI PHONE NO : 516-273-2200
100 SPENCE STREET SE DECISION MADE: 18-JUL-96
BAY SHORE, NY 11706-2290 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPERT SPINE MORPHOTIETRY REFERENCE
LUNAR CORP. 510(k) NO: K961007
ATTN: GARY SYRING PHONE NO : 608-274-4468
313 WEST BELTLINE HIGHWAY SE DECISION MADE: 25-JUL-96
MADISON, WI 53713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNAR REPORT GENERATOR
LUNAR CORP. 510(k) NO: K961944
ATTN: GARY SYRING PHONE NO : 608-274-4468
313 WEST BELTLINE HIGHWAY SE DECISION MADE: 03-JUL-96
MADISON, WI 53713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MBI FIBEROPTIC ENDO-ILLUMINATORM.B. INDUSTRIES, INC.
510(k) NO: K961036
ATTN: WAYNE C MOSHER PHONE NO :
1707 MADISON AVE. SE DECISION MADE: 15-JUL-96
GRANITE CITY, IL 62040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANAN PROSTATE LOCKING INTRODUCER SET
MANAN MEDICAL PRODUCTS, INC. 510(k) NO: K961377
ATTN: MICHAEL PLISHKA PHONE NO : 847-498-3333
2200 CARLSON DRIVE SE DECISION MADE: 03-JUL-96
NORTHBROOK, IL 60062 510(k) STATEMENT
DEVICE: TK40 - TILTMASTER
MECHANICAL APPLICATION DESIGNS, IN510(k) NO: K961744
ATTN: STACY LINDSEY PHONE NO : 713-391-8898
6819 HIGHWAY 90 BLVD. SE DECISION MADE: 25-JUL-96
SUITE 580 510(k) SUMMARY AVAILABLE FROM FDA
KATY, TX 77494
DEVICE: MEDCARE TRACHEOSTOMY CARE TRAY
MEDCARE MEDICAL GROUP, INC. 510(k) NO: K961167
ATTN: CRAIG J BELL PHONE NO : 800-243-2442
234 OLD HOMESTEAD HIGHWAY SE DECISION MADE: 02-JUL-96
EAST SWANZEY, NH 03446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCARE SUCTION CONNECTING TUBING
MEDCARE MEDICAL GROUP, INC. 510(k) NO: K961880
ATTN: CRAIG J BELL PHONE NO : 603-352-3230
234 OLD HOMESTEAD HWY., RT. 32 SE DECISION MADE: 19-JUL-96
EAST SWANZEY, NH 03466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP P-CATH
MEDCOMP 510(k) NO: K953811
ATTN: MICHELLE DEMERS PHONE NO :
1499 DELP DRIVE SE DECISION MADE: 25-JUL-96
HARLEYSVILLE, PA 19438 510(k) STATEMENT
DEVICE: MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
MEDEX, INC. 510(k) NO: K955231
ATTN: J H RUFFIN BOOTH PHONE NO : 770-623-9809
11360 TECHNOLOGY CIRCLE SE DECISION MADE: 18-JUL-96
DULUTH, GA 30136 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.V. ADMINISTRATION SETS
MEDICAL ASSOCIATES NETWORK, INC. 510(k) NO: K955821
ATTN: ROBERT T MERRICK PHONE NO : 818-353-2639
10572 MAHONEY DRIVE SE DECISION MADE: 10-JUL-96
SUNLAND, CA 91040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXTERITY PNEUMO SLEEVE SET
MEDICAL CREATIVE TECHNOLOGIES, INC510(k) NO: K962147
ATTN: PERK CROOK PHONE NO : 215-997-9689
2950-N ADVANCE LANE SE DECISION MADE: 09-JUL-96
COLMAR, PA 18915-9727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENON LIGHTSOURCE
MEDICAL DEVICE CONSULTANTS, INC. 510(k) NO: K962365
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 18-JUL-96
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD TECH BIOPSY SET FOR BONE AND BONE MARROW
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K961959
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
4445 S.W. 35TH TERRACE SE DECISION MADE: 19-JUL-96
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPX, CCM, CATH WITH 15% CO2
MEDICAL GRAPHICS CORP. 510(k) NO: K955432
ATTN: MICHAEL G SNOW PHONE NO : 612-484-4874
350 OAK GROVE PKWY. SE DECISION MADE: 01-JUL-96
ST. PAUL, MN 55127-8599 510(k) STATEMENT
DEVICE: BAGRIGHT CHILD RESUSCITATOR
MEDICAL MARKETING CONCEPTS 510(k) NO: K961329
ATTN: BOB MARTIN PHONE NO : 800-593-5188
2310 YORK RD. SE DECISION MADE: 02-JUL-96
ROANOKE, VA 24015 510(k) STATEMENT
DEVICE: BAGRIGHT INFANT RESUSCITATOR
MEDICAL MARKETING CONCEPTS 510(k) NO: K961330
ATTN: BOB MARTIN PHONE NO : 800-593-5188
2310 YORK RD. SE DECISION MADE: 02-JUL-96
ROANOKE, VA 24015 510(k) STATEMENT
DEVICE: PISTON SYRINGE
MEDICAL SURGICAL INTL. 510(k) NO: K955606
ATTN: JERRY C O'BRIEN PHONE NO :
13251 N. 99TH PLACE SE DECISION MADE: 25-JUL-96
SCOTTSDALE, AZ 85260 510(k) STATEMENT
DEVICE: MLI SOFT TISSUE SCREW & WASHER SYSTEM
MEDICINE LODGE, INC. 510(k) NO: K962194
ATTN: BRIAN T CLEARY PHONE NO : 916-646-5441
819 STRIKER AVE., SUITE 10 SE DECISION MADE: 30-JUL-96
SACRAMENTO, CA 95834-5432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION QID BLOOD GLUCOSE TEST STRIP
MEDISENSE, INC. 510(k) NO: K962295
ATTN: MICHAEL HALPIN PHONE NO : 617-895-6289
266 SECOND AVENUE SE DECISION MADE: 26-JUL-96
WALTHAM, MA 02154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE TITANIUM HEMOCLIPS
MEDLINE INDUSTRIES, INC. 510(k) NO: K962016
ATTN: LARA N SIMMONS PHONE NO : 847-949-2639
ONE MEDLINE PLACE SE DECISION MADE: 24-JUL-96
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: PATIENT EXAMINATION GLOVE (POWDERED)
MEDLINE PRODUCTS CO. LTD. 510(k) NO: K954293
ATTN: RAJEEV KUMAR SOOD PHONE NO :
85 MOO 4 HATYAI-CHANA HIGHWAY SE DECISION MADE: 26-JUL-96
NAMOM SUB-DISTRICT 510(k) STATEMENT
SONGKHLA,
DEVICE: HEART 400 ECG TRANSMITTER
MEDSYS INC. 510(k) NO: K953762
ATTN: GEORGE MYERS PHONE NO : 201-438-2310
201 ROUTE 17 SE DECISION MADE: 18-JUL-96
RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652
MEDTRONIC PS MEDICAL 510(k) NO: K961336
ATTN: TOM HOLDYCH PHONE NO :
125 CREMONA DR. SE DECISION MADE: 18-JUL-96
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSVENOUS, PERMANENT TINED TARGET TIP PACING
LEADS/TRANSVENOUS
MEDTRONIC, INC. 510(k) NO: K961679
ATTN: NORA K HADDING PHONE NO : 612-574-4189
7000 CENTRAL AVENUE, N.E. SE DECISION MADE: 30-JUL-96
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPUNCRIT (MODEL DRC-40)
MICRO DIAGNOSTICS CORP. 510(k) NO: K961803
ATTN: RODNEY A KATZER PHONE NO : 610-694-9770
170-57 S. COMMERCE WAY SE DECISION MADE: 05-JUL-96
BETHLEHEM, PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
MILL-ROSE LABORATORY 510(k) NO: K962736
ATTN: ALAN C POJE PHONE NO : 216-255-7995
7310 CORPORATE BLVD. SE DECISION MADE: 29-JUL-96
MENTOR, OH 44060-4885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIOX 3000 OXYGEN MONITOR
MINE SAFETY APPLIANCES, CO. 510(k) NO: K961644
ATTN: THOMAS P MCCLORY PHONE NO : 412-776-8600
300 WALDEN ROAD SE DECISION MADE: 25-JUL-96
MARS, PA 16066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M RED DOT ECG LEAD WIRES A
MINNESOTA MINING AND MFG. CO. 510(k) NO: K954900
ATTN: LINDA JOHNSON PHONE NO : 612-737-4376
3M CENTER, BLDG 275-3E-08 SE DECISION MADE: 15-JUL-96
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTER OPTICAL GLASSES
MIRAGE EYEWEAR 510(k) NO: K962298
ATTN: FU-LIN HU PHONE NO : 818-293-5729
961 MERIDIAN AVE. SE DECISION MADE: 25-JUL-96
ALHAMBRA, CA 91803 510(k) STATEMENT
DEVICE: MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
MISTEN MEDICAL CORP. 510(k) NO: K962163
ATTN: GEORGE W MURRAY PHONE NO : 901-756-1326
7220 STOUT RD. SE DECISION MADE: 25-JUL-96
GERMANTOWN, TN 38138 510(k) STATEMENT
DEVICE: HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30
PR
MORAX 510(k) NO: K960029
ATTN: JANIK BOREK PHONE NO : 313-475-1584
13805 WATERLOO ROAD SE DECISION MADE: 17-JUL-96
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2
IF
MORAX 510(k) NO: K960669
ATTN: BOREK JANIK PHONE NO : 313-475-2441
13805 WATERLOO ROAD SE DECISION MADE: 12-JUL-96
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
MRI DEVICES CORP. 510(k) NO: K961366
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 03-JUL-96
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: INTROSTAT LEAD INTRODUCER
MSI, INC. 510(k) NO: K960200
ATTN: LARRY G JUNKER PHONE NO :
615 JASMINE AVE., NORTH SE DECISION MADE: 02-JUL-96
TARPON SPRINGS, FL 34689 510(k) STATEMENT
DEVICE: NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS
NALTIAC MEDICAL, INC. 510(k) NO: K961717
ATTN: WENDEL LLOYD PHONE NO : 214-437-9356
17194 PRESTON RD. SE DECISION MADE: 18-JUL-96
SUITE 123-206 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75248
DEVICE: NHMC URETHRAL CATHETERIZATION TRAY
NATIONAL HEALTHCARE MFG. CORP. 510(k) NO: K962254
ATTN: BOB JACKSON PHONE NO : 204 885 5555
251 SAULTEAUX CRESCENT SE DECISION MADE: 29-JUL-96
WINNIPEG, MANITOBA, 510(k) STATEMENT
DEVICE: NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200
DISP
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K955642
ATTN: DAVID GREEN PHONE NO :
11150 THOMPSON AVE. SE DECISION MADE: 02-JUL-96
LENEXA, KS 66219-7285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIDOS 5003 HOLTER SYSTEM
NEW PRODUCT DEVELOPMENT, INC. 510(k) NO: K952969
ATTN: DONALD R GREENFIELD PHONE NO : 315-434-8873
6700 OLD COLLAMER ROAD SE DECISION MADE: 16-JUL-96
EAST SYRACUSE, NY 13057-1118 510(k) STATEMENT
DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING
HORMONE
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K961650
ATTN: DAVE D SMITH PHONE NO : 800-642-4657
33608 ORTEGA HIGHWAY SE DECISION MADE: 16-JUL-96
SAN JUAN CAPISTRANO, CA 92690-6130510(k) STATEMENT
DEVICE: HUMAN GROWTH HORMONE IMMUNOASSAY KIT
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K961678
ATTN: DAVE D SMITH PHONE NO : 800-642-4657
33608 ORTEGA HIGHWAY SE DECISION MADE: 08-JUL-96
SAN JUAN CAPISTRANO, CA 92690-6130510(k) STATEMENT
DEVICE: NIKE V8 AND NIKE V12
NIKE, INC. 510(k) NO: K962412
ATTN: JOHN B DUBECK PHONE NO : 202-434-4125
10001 G STREET, N.W. SE DECISION MADE: 03-JUL-96
SUITE 500W 510(k) STATEMENT
WASHINGTON, DC 20001
DEVICE: MIRUSCONE ABUTMENT SYSTEM
NOBELPHARMA USA, INC. 510(k) NO: K961728
ATTN: MARY EDWARDS PHONE NO : 708-654-9100
777 OAKMONT LANE, SUITE 100 SE DECISION MADE: 10-JUL-96
WESTMONT, IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 17 ANGULATED ABUTMENT
NOBELPHARMA USA, INC. 510(k) NO: K961736
ATTN: MARY EDWARDS PHONE NO : 708-654-9100
777 OAKMONT LANE SE DECISION MADE: 18-JUL-96
WESTMONT, IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERA ONE ABUTMENT SYSTEM
NOBELPHARMA USA, INC. 510(k) NO: K961737
ATTN: MARY EDWARDS PHONE NO : 708-654-9100
777 OAKMONT LANE SE DECISION MADE: 10-JUL-96
WESTMONT, IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE
NOBELPHARMA USA, INC. 510(k) NO: K962130
ATTN: MARY EDWARDS PHONE NO : 708-654-9100
777 OAKMONT LANE, SUITE 100 SE DECISION MADE: 22-JUL-96
WESTMONT, IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D SCOPE
OKTAS 510(k) NO: K961182
ATTN: DEBBIE IAMPIETRO PHONE NO :
134 FLANDERS ROAD SE DECISION MADE: 19-JUL-96
WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
OLYMPUS AMERICA, INC. 510(k) NO: K961274
ATTN: LAURA STORMS-TYLER PHONE NO :
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 05-JUL-96
MELVILLE, NY 11747-3157 510(k) STATEMENT
DEVICE: OLYMPUS BASKET GRASPERS (UROLOGY)
OLYMPUS AMERICA, INC. 510(k) NO: K961611
ATTN: BARRY E SANDS PHONE NO : 516-844-5474
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 18-JUL-96
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS FB SERIES BIOPSY FORCEPS
OLYMPUS AMERICA, INC. 510(k) NO: K962555
ATTN: BARRY E SANDS PHONE NO : 516-844-5474
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 30-JUL-96
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MB/BACT MYCROBACTERIA DETECTION SYSTEM
ORGANON TEKNIKA CORP. 510(k) NO: K954468
ATTN: ANN M QUINN PHONE NO : 919-620-2634
100 AKZO AVE. SE DECISION MADE: 22-JUL-96
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM
SIZES]
ORIGIN MEDSYSTEMS, INC. 510(k) NO: K960936
ATTN: ANTHONY DURSO PHONE NO : 415-617-5000
135 CONSTITUTION DR. SE DECISION MADE: 24-JUL-96
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BI-LOC BIPOLAR CUP
ORTHO DEVELOPMENT CORP. 510(k) NO: K961793
ATTN: MICHELLE M PERRY PHONE NO : 801-553-9991
106 WEST 12200 SOUTH SE DECISION MADE: 26-JUL-96
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: OSTEOMARK
OSTEX INTL., INC. 510(k) NO: K961562
ATTN: NANCY MALLINAK PHONE NO : 206-292-8082
2203 AIRPORT WAY SOUTH SE DECISION MADE: 11-JUL-96
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
SEATTLE, WA 98134
DEVICE: VITALMAX 4100
PACE TECH, INC. 510(k) NO: K953795
ATTN: ILHAN M BILGUTAY PHONE NO : 813-442-8118
510 GARDEN AVENUE SE DECISION MADE: 01-JUL-96
CLEARWATER, FL 34615-4126 510(k) STATEMENT
DEVICE: PACEART WRIST ELECTRODES
PACEART, INC. 510(k) NO: K960721
ATTN: MICHAEL BERGLESON, PH.D. PHONE NO : 201-696-1122
22 RIVERVIEW DRIVE SE DECISION MADE: 18-JUL-96
WAYNE, NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL SL-YZ5E
PACIFIC OPHTHALMIC SUPPLY 510(k) NO: K962522
ATTN: WILL MARKLE PHONE NO : 415-637-9391
1920 OAK KNOLL DR. SE DECISION MADE: 25-JUL-96
BELMONT, CA 94002 510(k) STATEMENT
DEVICE: MARPP PRESSURE MONITORING SYSTEM
PARADIGM MEDICAL, INC. 510(k) NO: K960725
ATTN: LARRY KLUGE PHONE NO :
1955 RAYMOND DR. SE DECISION MADE: 15-JUL-96
SUITE 103 510(k) STATEMENT
NORTHBROOK, IL 60062
DEVICE: QUIK-FIL VAPORIZER KEYED FILLER
PENLON LIMITED 510(k) NO: K961468
ATTN: ALAN C GREEN PHONE NO : 012 355 55252
ABINGDON SE DECISION MADE: 16-JUL-96
OXFORDSHIRE, 510(k) STATEMENT
DEVICE: EG-2940, VIDEO GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K961564
ATTN: PAUL SILVA PHONE NO : 305-430-1443
3117 COMMERCE PARKWAY SE DECISION MADE: 09-JUL-96
MIRAMAR, FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ED-344OT
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K961568
ATTN: PAUL SILVA PHONE NO : 305-430-1443
3117 COMMERCE PARKWAY SE DECISION MADE: 09-JUL-96
MIRAMAR, FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSTICK ONE STEP PREGNANCY TEST(9010)
PHAMATECH 510(k) NO: K962219ATTN: TUAN PHAM
PHONE NO : 619-635-5840
9265 ACTIVITY ROAD SE DECISION MADE: 23-JUL-96
SUITE 112-113 510(k) SUMMARY AVAILABLE FROM FDA
SANDIEGO, CA 92126
DEVICE: FLEXIBLE PHASED ARRAY SPINE COIL
PICKER INTERNATIOANL, INC. 510(k) NO: K960497
ATTN: ELAINE K KEELER, PH.D. PHONE NO : 216-473-5591
5500 AVION PARK DRIVE SE DECISION MADE: 05-JUL-96
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISM 3000XPV SYSTEM (210714)
PICKER INTL., INC. 510(k) NO: K961577
ATTN: NORMAN J YAGER PHONE NO : 216-473-7652
595 MINER ROAD SE DECISION MADE: 23-JUL-96
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)
PICKER INTL., INC. 510(k) NO: K961637
ATTN: ELAINE K KEELER, PH.D. PHONE NO : 216-473-5591
5500 AVION PARK DRIVE SE DECISION MADE: 03-JUL-96
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBER-SPLINT ML MULTILAYER
POLYDENTIA USA 510(k) NO: K962374
ATTN: ROBERT W BAUER PHONE NO : 312-226-3932
1819 SO. MAY STREET SE DECISION MADE: 22-JUL-96
2F 510(k) STATEMENT
CHICAGO, IL 60608
DEVICE: BOSTON CONTACT LENS CASE
POLYMER TECHNOLOGY DIV. WILMINGTON510(k) NO: K962512
ATTN: BEVERLEY A DOYLE PHONE NO : 508-658-6111
100 RESEARCH DRIVE SE DECISION MADE: 12-JUL-96
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
POLYMER TECHNOLOGY INTERNATIONAL 510(k) NO: K953672
ATTN: ESTELA FIGUEROA PHONE NO :
1871 N.W. GILMAN BLVD. SE DECISION MADE: 01-JUL-96
ISSAQUAH, WA 98027 510(k) STATEMENT
DEVICE: PORT-A-POLE
PRINS MEDICAL IND., INC. 510(k) NO: K961470
ATTN: JAMES L PRINS PHONE NO : 805-482-2280
4360 E. MAIN ST. #438 SE DECISION MADE: 22-JUL-96
VENTURA, CA 91360 510(k) STATEMENT
DEVICE: BURLEW INFANT HOOD
PROMEDIC, INC. 510(k) NO: K962182
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW CT. SE DECISION MADE: 15-JUL-96
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN-THE-EAR
QUALITONE 510(k) NO: K961827
ATTN: BRUCE BROWN PHONE NO : 800-328-3897
4931 WEST 35TH STREET SE DECISION MADE: 03-JUL-96
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
R & D SYSTEMS, INC. 510(k) NO: K961610
ATTN: KENNETH T EDDS, PH.D. PHONE NO : 612-379-2956
614 MCKINLEY PLACE N.E. SE DECISION MADE: 01-JUL-96
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D RETIC-PG HEMATOLOGY CONTROL
R & D SYSTEMS, INC. 510(k) NO: K961673
ATTN: JOHN G YAGER PHONE NO : 612-379-2956
614 MCKINLEY PLACE N.E. SE DECISION MADE: 15-JUL-96
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYESTER NONABSORBABLE SURGICAL SUTURES USP
R.K. MEDICAL, L.L.C. 510(k) NO: K961925
ATTN: BRENDA M KELLY, M.D. PHONE NO : 201-529-3111
ONE LETHBRIDGE PLAZA SE DECISION MADE: 29-JUL-96
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
MAHWAH, NJ 07430
DEVICE: PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
R.K. MEDICAL, L.L.C. 510(k) NO: K961931
ATTN: BRENDA M KELLY PHONE NO : 201-529-3111
ONE LETHBRIDGE PLAZA SE DECISION MADE: 29-JUL-96
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
MAHWAH, NJ 07430
DEVICE: ENDO-TECH LTD., TIPS
RATIO DESIGN LABS 510(k) NO: K961695
ATTN: TIM B LUSBY PHONE NO : 770-664-5797
4040 NINE MCFARLAND, SUITE 800 SE DECISION MADE: 01-JUL-96
ALPHERETTA, GA 30201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPR CARD TEST KIT
REMEL LIMITED PARTNERSHIP 510(k) NO: K955136
ATTN: DAVID A WALL PHONE NO :
P.O. BOX 16276 SE DECISION MADE: 29-JUL-96
AUGUSTA, GA 30919-2276 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPR LIQUID CONTROLS
REMEL LIMITED PARTNERSHIP 510(k) NO: K955143
ATTN: DAVID A WALL PHONE NO :
P.O. BOX 16276 SE DECISION MADE: 30-JUL-96
AUGUSTA, GA 30919-2276 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTAMICIN DISK (120MCG)
REMEL LIMITED PARTNERSHIP 510(k) NO: K961818
ATTN: MARY ANN SILVIUS PHONE NO : 913-888-0939
12076 SANTA FE DR. SE DECISION MADE: 10-JUL-96
LENEXA, KS 66215 510(k) STATEMENT
DEVICE: STREPTOMYCIN DISK (300MCG)
REMEL LIMITED PARTNERSHIP 510(k) NO: K961819
ATTN: MARY ANN SILVIUS PHONE NO : 913-888-3594
12076 SANTA FE DR. SE DECISION MADE: 10-JUL-96
LENEXA, KS 66215 510(k) STATEMENT
DEVICE: WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
RENAISSANCE PHARMACEUTICAL, INC. 510(k) NO: K961316
ATTN: DARELENE TAYLOR-MCCORD PHONE NO : 702-749-5840
33971 SELVA SUITE 100 SE DECISION MADE: 15-JUL-96
DANA POINT, CA 92629 510(k) STATEMENT
DEVICE: WOUND HYDROGEL & STERILE WOUND HYDROGEL
RENAISSANCE PHARMACEUTICAL, INC. 510(k) NO: K961766
ATTN: DARLENE TAYLOR-MCCORD PHONE NO : 702-586-8177
P.O. BOX 216 SE DECISION MADE: 15-JUL-96
GLENBROOK, NV 89413 510(k) STATEMENT
DEVICE: RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2
SYSTEM
RESCARE LIMITED 510(k) NO: K952429
ATTN: ALAN DONALD PHONE NO :
3377 NORTH TORREY PINES COURT SE DECISION MADE: 02-JUL-96
SUITE 300 510(k) STATEMENT
LA JOLLA, CA 92037
DEVICE: BIPAP MODEL S/T-D
RESPIRONICS, INC. 510(k) NO: K951264
ATTN: DENNIS S METENY PHONE NO : 412-733-0202
1001 MURRY RIDGE DRIVE SE DECISION MADE: 29-JUL-96
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO CPAP SYSTEM
RESPIRONICS, INC. 510(k) NO: K961626
ATTN: FRANCIS X DOBSCHA PHONE NO : 412-733-0200
1001 MURRY RIDGE DR. SE DECISION MADE: 18-JUL-96
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFINDER 700 HOLTER ANALYZER
REYNOLDS MEDICAL LIMITED 510(k) NO: K951902
ATTN: GEORGE MYERS PHONE NO : 201-438-2310
201 ROUTE 17 SE DECISION MADE: 15-JUL-96
RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND
DIGOXIN
ROCHE DIAGNOSTIC SYSTEMS 510(k) NO: K961824
ATTN: MARIA FEIJOO PHONE NO : 908-253-7310
BRANCHBURG TOWNSHIP SE DECISION MADE: 23-JUL-96
1080 U.S. HIGHWAY 202 510(k) SUMMARY AVAILABLE FROM FDA
BRANCHBURG, NJ 08876-3771
DEVICE: ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
ROCHE DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K961726
ATTN: MARIA FEIJOO PHONE NO : 908-253-7310
1080 U.S. HIGHWAY 202 SE DECISION MADE: 11-JUL-96
BRANCHBURG, NJ 08876-1760 510(k) STATEMENT
DEVICE: ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
ROCKET MEDICAL PLC 510(k) NO: K961287
ATTN: L TODD PHONE NO : 019 141 66776
FACTORIES 3 & 4, SE DECISION MADE: 26-JUL-96
WEAR INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, TYNE & WEAR,
DEVICE: RX TEXTILES STERILE STOCKINETTE
RX TEXTILES, INC. 510(k) NO: K960803
ATTN: JOSEPH A DAVANT III PHONE NO : 704-283-9787
3107 CHAMBER DR. SE DECISION MADE: 12-JUL-96
MONROE, NC 28110 510(k) STATEMENT
DEVICE: SAS SICKLE CELL TEST
SA SCIENTIFIC, INC. 510(k) NO: K960947
ATTN: HARBI SHADFAN PHONE NO :
4919 GOLDEN QUAIL SE DECISION MADE: 01-JUL-96
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
SAFETEC OF AMERICA, INC. 510(k) NO: K960048
ATTN: ROBERT O DEAN PHONE NO : 716-895-1822
1055 EAST DELAVAN AVENUE SE DECISION MADE: 12-JUL-96
BUFFALO, NY 14215 510(k) STATEMENT
DEVICE: EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP
SAFETEC OF AMERICA, INC. 510(k) NO: K960073
ATTN: ROBERT O DEAN PHONE NO : 716-895-1822
1055 EAST DELAVAN AVENUE SE DECISION MADE: 12-JUL-96
BUFFALO, NY 14215 510(k) STATEMENT
DEVICE: MUCUS SPECIMEN TRAP
SAGE PRODUCTS, INC. 510(k) NO: K962168
ATTN: KAREN PINTO PHONE NO : 815-455-4700
815 TEK DR. SE DECISION MADE: 22-JUL-96
CRYSTAL LAKE, IL 60014 510(k) STATEMENT
DEVICE: SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
SALTER LABORATORIES 510(k) NO: K961476
ATTN: JAMES N CURTI PHONE NO : 805-854-3166
100 WEST SYCAMORE RD. SE DECISION MADE: 16-JUL-96
ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANPOINT MENSTRUAL TAMPON
SANPOINT AB 510(k) NO: K961926
ATTN: HANS FEIKES DE GROOT PHONE NO : 416 591 0610
P.O. BOX 55 SE DECISION MADE: 15-JUL-96
MARIEFRED, 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLSTENT ENTERAL ENDOPROTHESIS
SCHNEIDER (USA) INC. 510(k) NO: K954290
ATTN: KATHY JO FAHEY PHONE NO : 612-550-5500
5905 NATHAN LANE SE DECISION MADE: 10-JUL-96
MINNEAPOLIS, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
SCHNEIDER (USA) INC. 510(k) NO: K961296
ATTN: CATHY YOHNK PHONE NO : 612-550-5500
5905 NATHAN LANE SE DECISION MADE: 10-JUL-96
MINNEAPOLIS, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
SCHNEIDER (USA) INC. 510(k) NO: K961507
ATTN: CATHY YOHNK PHONE NO : 612-550-5848
5905 NATHAN LANE SE DECISION MADE: 10-JUL-96
MINNEAPOLIS, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCUGLIDE
SCIENTIFIC DEVICE MANUFACTURER LLC510(k) NO: K960917
ATTN: RICHARD C BALL PHONE NO : 415-454-9370
999 ANDERSEN DRIVE, SUITE 120 SE DECISION MADE: 02-JUL-96
SAN RAFAEL, CA 94901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCIMED DISPATCH GOLD CORONARY CATHETER
SCIMED LIFE SYSTEMS, INC. 510(k) NO: K961294
ATTN: DEBORAH A FRANK PHONE NO : 800-553-5878
ONE SCIMED PLACE SE DECISION MADE: 03-JUL-96
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTRY RADIOTRANSLUCENT ECG ELECTRODES
SENTRY MEDICAL PRODUCTS, INC. 510(k) NO: K962122
ATTN: JAMES G STROKES PHONE NO : 708-932-5300
331 S. EISENHOWER LANE SE DECISION MADE: 24-JUL-96
LOMBARD, IL 60148 510(k) STATEMENT
DEVICE: DTX-200 BONE DENSITOMETER
SHOTWELL & CARR, INC. 510(k) NO: K961011
ATTN: BERT HUDSON PHONE NO : 214-243-1634
3003 LBJ FREEWAY SE DECISION MADE: 05-JUL-96
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75234-7755
DEVICE: SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA
162E,166
SIEMENS HEARING INSTRUMENTS, INC. 510(k) NO: K962170
ATTN: GARY W ROESEL PHONE NO : 908-562-6600
10 CONSTITUTION AVE. SE DECISION MADE: 25-JUL-96
PISCATAWAY, NJ 08855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
SIEMENS MEDICAL SYSTEMS 510(k) NO: K955743
ATTN: TOM CONNELLY PHONE NO : 508-750-7500
16 ELECTRONICS AVE. SE DECISION MADE: 08-JUL-96
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPALIS CMV TOTAL ANTIBODY ASSAY
SIENNA BIOTECH, INC. 510(k) NO: K955799
ATTN: JOYCE T DAVID PHONE NO : 301-656-3648
3 BETHESDA METRO CENTER SE DECISION MADE: 10-JUL-96
SUITE 750 510(k) SUMMARY AVAILABLE FROM FDA
BETHESDA, MD 20814
DEVICE: COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
SIERRA LABORATORIES, INC. 510(k) NO: K962384
ATTN: ANNA PEREZ PHONE NO : 602-624-0580
3520 SOUTH CAMPBELL AVE SE DECISION MADE: 15-JUL-96
TUCSON, AZ 85713 510(k) STATEMENT
DEVICE: COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
SIERRA LABORATORIES, INC. 510(k) NO: K962413
ATTN: ANNA PEREZ PHONE NO : 602-624-0580
3520 SOUTH CAMPBELL AVE SE DECISION MADE: 15-JUL-96
TUCSON, AZ 85713 510(k) STATEMENT
DEVICE: ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K961649
ATTN: TEDD GOSIAN PHONE NO : 508-339-9700
130 FORBES BOULEVARD SE DECISION MADE: 16-JUL-96
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
SMITH & NEPHEW UNITED, INC. 510(k) NO: K961775
ATTN: JIM IRVIN PHONE NO : 813-392-1261
11775 STARKLEY RD. SE DECISION MADE: 16-JUL-96
P.O.BOX 1970 510(k) STATEMENT
LARGO, FL 34649
DEVICE: STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
SOLARCARE TECHNOLOGIES 510(k) NO: K954326
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
1745 EATON AVENUE SE DECISION MADE: 23-JUL-96
BETHLEHEM, PA 18018 510(k) STATEMENT
DEVICE: STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
SOLARCARE TECHNOLOGIES CORP,INC. 510(k) NO: K954156
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
1745 EATON AVE SE DECISION MADE: 22-JUL-96
BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMA
SOMA INTERNATIONAL LTD. 510(k) NO: K962725
ATTN: B. K. MA PHONE NO : 272 253 11
75 MODY ROAD, TST EAST SE DECISION MADE: 25-JUL-96
KOWLOON, 510(k) STATEMENT
DEVICE: SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE
SOMNUS MEDICAL TECHNOLOGIES 510(k) NO: K961133
ATTN: THOMAS C WEHMAN PHONE NO :
21070 HOMESTEAD RD. SE DECISION MADE: 10-JUL-96
CUPERTINO, CA 94043 510(k) STATEMENT
DEVICE: SONY DKR-700 DIGITAL STILL RECORDER
SONY MEDICAL SYSTEMS 510(k) NO: K961680
ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434
C/O MEDICAL DEVICE CONSULT,INC SE DECISION MADE: 03-JUL-96
49 PLAIN STREET 510(k) SUMMARY AVAILABLE FROM FDA
NORTH ATTLEBORO, MA 02760
DEVICE: LUBRICATING JELLY, LOW VISCOSITY
SPAN-AMERICA MEDICAL SYSTEMS, INC.510(k) NO: K961502
ATTN: POLLY THOMPSON PHONE NO : 864-288-8877
70 COMMERCE DR. SE DECISION MADE: 18-JUL-96
GREENVILLE, SC 29615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RD-1200H NORMAL MODE RUBY LASER SYSTEM
SPECTRUM MEDICAL TECHNOLOGIES 510(k) NO: K955612
ATTN: ROBERT T HANDREN PHONE NO :
3499 WOODLEY PARK PL. SE DECISION MADE: 09-JUL-96
OVIDEO, FL 32765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY TROCER WITH SPRINGLOADED OBDURATOR
SPIESS DESIGN, INC. 510(k) NO: K960347
ATTN: DIETER KEPPEL PHONE NO : 847-550-1400
290 TELSER ROAD SE DECISION MADE: 01-JUL-96LAKE
ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE WAND
SPINTECH INC. 510(k) NO: K961648
ATTN: DANIEL J MANELLI PHONE NO : 202-833-0815
2000 M STREET, N.W., SUITE 700 SE DECISION MADE: 05-JUL-96
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: TOMOGRAPH ACCESSORIES
STERI-OSS, INC. 510(k) NO: K962120
ATTN: PAUL GASSER PHONE NO : 714-282-4853
22895 EAST PARK DRIVE SE DECISION MADE: 25-JUL-96
YORBA LINDA, CA 92687 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK
STORZ INSTRUMENT CO. 510(k) NO: K961820
ATTN: AUDREY SWEARINGEN PHONE NO : 314-225-5051
3365 TREE CT., SE DECISION MADE: 25-JUL-96
INDUSTRIAL BLVD. 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63122-6694
DEVICE: STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
STRATO/INFUSAID, INC. 510(k) NO: K960391
ATTN: CRAIG M AUDET PHONE NO : 617-255-6765
1400 PROVIDENCE HWY. SE DECISION MADE: 03-JUL-96
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER CEMENT REMOVAL SYSTEM
STRYKER CORP. 510(k) NO: K961101
ATTN: PHONE NO :
2725 FAIRFIELD ROAD SE DECISION MADE: 15-JUL-96
KALAMAZOO, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
STRYKER CORP. 510(k) NO: K961970
ATTN: DIANE DAVIS PHONE NO : 616-323-7700
2725 FAIRFIELD ROAD SE DECISION MADE: 26-JUL-96
KALAMAZOO, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCUSYSTEM ART ADVANTAGE
SURGICAL DESIGN CORPORATION 510(k) NO: K961243
ATTN: WAYNE H MATELSKI PHONE NO :
1050 CONNECTICUT AVENUE, NW SE DECISION MADE: 10-JUL-96
WASHINGTON, DC 20036-5339 510(k) STATEMENT
DEVICE: LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
SURGICAL IMAGE LABORATORIES, INC. 510(k) NO: K955845
ATTN: LEE STANKO PHONE NO :
1286 WEST NEWPORT CENTER DR. SE DECISION MADE: 05-JUL-96
DEERFIELD BEACH, FL 33442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
SYNTHES (USA) 510(k) NO: K962047
ATTN: ANGELA SILVESTRI PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 24-JUL-96
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: TUAT SPLATTER CONTROL SHIELD SCS-300
TAUT, INC. 510(k) NO: K962003
ATTN: GLENN B MILLER PHONE NO : 708-232-2507
2571 KANEVILLE COURT SE DECISION MADE: 18-JUL-96
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: URITEST - NITRITE IN URINE TEST
TECHNICAL CHEMICALS AND PRODUCTS I510(k) NO: K954685
ATTN: FRAN WHITE PHONE NO : 508-927-3808
15 OAK STREET SE DECISION MADE: 22-JUL-96
BEVERLY FARMS, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
TECHNICAL CHEMICALS AND PRODUCTS I510(k) NO: K954968
ATTN: FRAN WHITE PHONE NO :
15 OAK STREET SE DECISION MADE: 26-JUL-96
BEVERLY FARMS, MA 01915 510(k) STATEMENT
DEVICE: OMEGATRAC BY TEFTEC
TEFTEC CORP. 510(k) NO: K955240
ATTN: THOMAS E FINCH PHONE NO : 210-885-7588
6929 OLD SPRING BRANCH ROAD SE DECISION MADE: 01-JUL-96
SPRING BRANCH, TX 78070-5401 510(k) STATEMENT
DEVICE: MAXIM PF MODELS 033-581/033-590
TELECTRONICS PACING SYSTEMS, INC. 510(k) NO: K961118
ATTN: ANDREW CLEELAND PHONE NO : 303-790-8000
7400 SOUTH TUCSON WAY SE DECISION MADE: 15-JUL-96
ENGLEWOOD, CO 80112 510(k) STATEMENT
DEVICE: RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD)
COI
TERUMO MEDICAL CORP. 510(k) NO: K961445
ATTN: KEITH M SMITH PHONE NO : 410-392-7375
125 BLUE BALL ROAD SE DECISION MADE: 09-JUL-96
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSPACH "PATIENT FITTED" TEMPOROMANDIBULAR JOINT PROSTHESIS
THE ANSPACH EFFORT, INC. 510(k) NO: K954224
ATTN: WILLIAM E ANSPACH PHONE NO : 407-220-8855
4500 RIVERSIDE DRIVE SE DECISION MADE: 17-JUL-96
PALM BEACH GARDENS, FL 33410 510(k) STATEMENT
DEVICE: STERNGOLD G-HARD METAL ALLOY
THE STERN METALS CO., INC. 510(k) NO: K962301
ATTN: NICHOLAS J SAVARESE PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 18-JUL-96
ATTLEBORO, MA 02703 510(k) STATEMENT
DEVICE: POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN
CONTENT) P
TILLOTSON HEALTHCARE CORP. 510(k) NO: K960225
ATTN: IMOGENE TIBBETTS PHONE NO : 603-472-6600
360 ROUTE 101 SE DECISION MADE: 29-JUL-96
BEDFORD, NH 03110-5030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION
GLOVE
TILLOTSON HEALTHCARE CORP. 510(k) NO: K960247
ATTN: IMOGENE TIBBETTS PHONE NO : 800-445-6830
360 ROUTE 101 SE DECISION MADE: 29-JUL-96
BEDFORD, NH 03110-5030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXART QD HEAD/NECK COIL
TOSHIBA AMERICA MRI, INC. 510(k) NO: K961391
ATTN: JAVAD SEYEDZADEH PHONE NO : 714-730-5000
280 UTAH AVE. SE DECISION MADE: 09-JUL-96
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODILY FLUID DISPOSAL KIT
TRANSIDYNE GENERAL CORP. 510(k) NO: K961217
ATTN: STEVEN W BUTLER PHONE NO : 800-325-8995
400 HERALD JOURNAL PARK SE DECISION MADE: 25-JUL-96
SPARTANBURG, SC 29303 510(k) STATEMENT
DEVICE: TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
TREND SCIENTIFIC, INC. 510(k) NO: K955755
ATTN: MARIELLYN TRUAX PHONE NO :
368 WEST COUNTY RD. D SE DECISION MADE: 11-JUL-96
NEW BRIGHTON, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITYS OR ELITYS-E
TROPHY RADIOLOGIE 510(k) NO: K962337
ATTN: MARIE PIERRE LABAT-CAMY PHONE NO : 331 495 737373891
106, RUE DE LA JARRY, BP 20 SE DECISION MADE: 25-JUL-96
VINCENNES CEDEX, 510(k) STATEMENT
DEVICE: CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
TTK BIOMED, LTD. 510(k) NO: K955772
ATTN: RICHARD D MANTHEI PHONE NO :
1575 EYE STREET, N.W. SE DECISION MADE: 08-JUL-96
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE ENDOSCOPIC ACCESSORY HANDLE
U.S. ENDOSCOPY GROUP, INC. 510(k) NO: K961762
ATTN: GRETCHEN YOUNKER PHONE NO : 216-639-4494
9330 PROGRESS PKWY. SE DECISION MADE: 22-JUL-96
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
ULTRADENT PRODUCTS, INC. 510(k) NO: K960696
ATTN: L.M. CHATWIN PHONE NO : 801-572-4200
505 WEST 10200 SOUTH SE DECISION MADE: 18-JUL-96
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: RADIOGRAPHIC FILM CASSETTES
UNIDEX GROUP, INC. 510(k) NO: K962336
ATTN: HENRY LEE PHONE NO : 847-299-0300
2400 EAST DEVON AVE., SE DECISION MADE: 03-JUL-96
SUITE 205 510(k) STATEMENT
DES PLAINES, IL 60018
DEVICE: RADIOGRAPHIC GRID
UNIDEX GROUP, INC. 510(k) NO: K962338
ATTN: HENRY LEE PHONE NO : 847-299-0300
2400 EAST DEVON AVE. SE DECISION MADE: 03-JUL-96
DES PLAINES, IL 60018 510(k) STATEMENT
DEVICE: UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
UNITED BIOTECH, INC. 510(k) NO: K962211
ATTN: WUAN T LU PHONE NO : 415-961-2910
110 PIONEER WAY, #C SE DECISION MADE: 08-JUL-96
MOUNTAIN VIEW, CA 94041-1517 510(k) STATEMENT
DEVICE: SUTURE ANCHOR
UNITED STATES SURGICAL CORP. 510(k) NO: K961578
ATTN: JANET G JOHNSON PHONE NO : 203-845-1000
150 GLOVER AVE. SE DECISION MADE: 10-JUL-96
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL DYNAMICS POP RIVET
UNITED STATES SURGICAL CORP. 510(k) NO: K961585
ATTN: JANET G JOHNSON PHONE NO : 203-845-1000
150 GLOVER AVE. SE DECISION MADE: 10-JUL-96
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO SUTURE CHEMOSITE TUNNELER
UNITED STATES SURGICAL CORP. 510(k) NO: K961856
ATTN: JANET G JOHNSON PHONE NO : 203-845-1000
150 GLOVER AVE. SE DECISION MADE: 18-JUL-96
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE
UNITED STATES SURGICAL CORP. 510(k) NO: K961997
ATTN: JONATHAN GILBERT PHONE NO : 203-845-1000
150 GLOVER AVE. SE DECISION MADE: 16-JUL-96
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAN 500
UTAH MEDICAL PRODUCTS, INC. 510(k) NO: K961424
ATTN: KEVIN L CORNWELL PHONE NO : 800-533-4984
7043 SO. 300 WOUTH SE DECISION MADE: 10-JUL-96
MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR
PURI
UV TECHNOLOGIES, INC. 510(k) NO: K960833
ATTN: ANNE MARIE CESARIO PHONE NO :
1129 BLOOMFIELD AVE. SE DECISION MADE: 25-JUL-96
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: MCCOY CELL CULTURES
VAI DIAGNOSTICS, INC. 510(k) NO: K955608
ATTN: ROBERT F NAEGELE PHONE NO : 901-377-0721
5171 WILFONG ROAD SE DECISION MADE: 08-JUL-96
MEMPHIS, TN 38134 510(k) STATEMENT
DEVICE: APLLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE
AFTERLOA
VARIAN ASSOC., INC. 510(k) NO: K955844
ATTN: CHARLES H WILL PHONE NO : 415-493-4000
3045 HANOVER STREET SE DECISION MADE: 26-JUL-96
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAX-D THERAPEUTIC TABLE
VAT-TECH, INC. 510(k) NO: K951622
ATTN: ELIZABETH A RIEGEL PHONE NO :
38511 US 19, SE DECISION MADE: 02-JUL-96
CONNELL SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
PALM HARBOR, FL 34684
DEVICE: VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM
VIDENT 510(k) NO: K961434
ATTN: RAY E MORROW PHONE NO : 714-961-6200
3150 EAST BIRCH ST. SE DECISION MADE: 08-JUL-96
BREA, CA 92621-6250 510(k) STATEMENT
DEVICE: DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
VISION SCIENCES, INC. 510(k) NO: K961591
ATTN: PAMELA L PAPINEAU PHONE NO : 508-650-9971
6 STRATHMORE RD. SE DECISION MADE: 02-JUL-96
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE
WALLACE A. ERICKSON & CO. 510(k) NO: K960667
ATTN: ABNER T DELA CRUZ PHONE NO : 312-327-9457
1920 NORTH CLYBOURN AVE. SE DECISION MADE: 02-JUL-96
CHICAGO, IL 60614 510(k) STATEMENT
DEVICE: ALLIANCE 2690 SEPARATIONS MODULE
WATERS CORP. 510(k) NO: K961557
ATTN: VIRGINIA L CORBIN PHONE NO : 508-482-2000
34 MAPLE ST. SE DECISION MADE: 05-JUL-96
MILFORD, MA 01757-3696 510(k) STATEMENT
DEVICE: WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
WATERS CORP. 510(k) NO: K962574
ATTN: VIRGINIA L CORBIN PHONE NO : 508-482-2000
34 MAPLE STREET SE DECISION MADE: 22-JUL-96
MILFORD, MA 01757-3696 510(k) STATEMENT
DEVICE: COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC,
LOW
WEMBLEY RUBBER PRODUCTS (M) SDN BH510(k) NO: K962188
ATTN: CHOW YUE WAH PHONE NO : 603 846 1486
LOT 1, JALAN 3, SE DECISION MADE: 26-JUL-96
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR,
DEVICE: COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC,
LOW
WEMBLEY RUBBER PRODUCTS (M) SDN BH510(k) NO: K962189
ATTN: CHOW YUE WAH PHONE NO : 603 846 1486
LOT 1, JALAN 3, SE DECISION MADE: 26-JUL-96
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR,
DEVICE: WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL,
TRIANG
WILO MEDIZINTECHNIK LOTHAR WILBERG510(k) NO: K955792
ATTN: MARK HELLER PHONE NO : 202-457-6000
2550 M STREET, N.W. SE DECISION MADE: 26-JUL-96
WASHINGTON, DC 20037 510(k) STATEMENT
DEVICE: TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL
KNE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K961900
ATTN: KIM TOMPKINS PHONE NO : 901-867-4731
5677 AIRLINE RD. SE DECISION MADE: 25-JUL-96
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XRT 400
WUESTEC MEDICAL INC. 510(k) NO: K955414
ATTN: JIM MILLER PHONE NO :
421 HOLCOMBE AVE. SE DECISION MADE: 24-JUL-96
MOBILE, AL 36606-1541 510(k) STATEMENT
DEVICE: MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
WUESTEC MEDICAL INC. 510(k) NO: K960083
ATTN: JIM MILLER PHONE NO :
421 HOLCOMBE AVE. SE DECISION MADE: 24-JUL-96
MOBILE, AL 36606-1541 510(k) STATEMENT
DEVICE: XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
XIAMEN CHINGSONG OPTICAL INDUSTRIA510(k) NO: K962382
ATTN: SUN-MOU LEE PHONE NO : 86 592 6252318
23 SHIN YUNG ROAD SE DECISION MADE: 25-JUL-96
XIAMEN, FUCHIEN, 510(k) STATEMENT
DEVICE: ACTIVENT ANTIMICROBIAL VENTILATION TUBES
XOMED, INC. 510(k) NO: K961873ATTN: DAVID
TIMLIN PHONE NO : 904-296-9600
6743 SOUTHPOINT DR. N. SE DECISION MADE: 01-JUL-96
JACKSONVILLE, FL 32216-0980 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
YELLOW SPRINGS INSTRUMENT CO., INC510(k) NO: K962070
ATTN: JAMES R GRAVER PHONE NO : 513-767-7241
1725 BRANNUM LANE SE DECISION MADE: 19-JUL-96
YELLOW SPRINGS, OH 45387 510(k) STATEMENT
DEVICE: VZV IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K961012
ATTN: MARK J KOPNITSKY PHONE NO :
200 EVANS WAY SE DECISION MADE: 24-JUL-96
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: MUMPS IGG TEST
ZEUS SCIENTIFIC, INC. 510(k) NO: K961204
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
P .O.BOX 38 SE DECISION MADE: 18-JUL-96
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS
W/CO-N
ZIMMER, INC. 510(k) NO: K960278
ATTN: LYNETTE WHITAKER PHONE NO :
P.O. BOX 708 SE DECISION MADE: 25-JUL-96
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLARLESS POLISHED TAPER HIP PROSTHESIS
ZIMMER, INC. 510(k) NO: K960658
ATTN: RUTH ANN WOOD PHONE NO : 219-372-4944
P.O. BOX 708 SE DECISION MADE: 16-JUL-96
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS
PERIOD 355
TOTAL WITH SUMMARIES
205
TOTAL WITH STATEMENTS
150
(Updated August 5, 1996)