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510(k)s Final Decisions Rendered for December 1999 |
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DEVICE: A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSUR
A & D ENGINEERING, INC. 510(k) NO: K993888(TRADITIONAL)
ATTN: JERRY WANG PHONE NO : 408-263-5333
1555 MC CANDLESS DR. SE DECISION MADE: 20-DEC-99
MILPITAS, CA 95035 510(k) STATEMENT
DEVICE: A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32,
A-MED SYSTEMS, INC. 510(k) NO: K991541(TRADITIONAL)
ATTN: ROBERTA THOMPSON PHONE NO : 916-375-7400
2491 BOATMAN AVE. SE DECISION MADE: 28-DEC-99
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRUCTOSAMINE, MODEL FR 106-01
A.P. TOTAL CARE, INC. 510(k) NO: K991246(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 16-DEC-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOT
ABBOTT LABORATORIES, INC. 510(k) NO: K994039(SPECIAL)
ATTN: JERRY JENNINGS PHONE NO : 847-935-4977
D-389, BLDG. AP30 SE DECISION MADE: 22-DEC-99
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064-3537
DEVICE: ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES
ACCUMETRICS INC. 510(k) NO: K992531(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 619-404-8235
3985 B SORRENTO VALLEY BLVD. SE DECISION MADE: 21-DEC-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
ACIST MEDICAL SYSTEMS 510(k) NO: K993774(SPECIAL)
ATTN: CARL M BEAURLINE PHONE NO : 612-955-9319
7450 FLYING CLOUDS DR. SE DECISION MADE: 07-DEC-99
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: ACON ONE STEP PREGNANCY TEST STRIP (URINE)
ACON LABORATORIES, INC. 510(k) NO: K993203(TRADITIONAL)
ATTN: NORA C.R. YORK PHONE NO : 858-535-2030
11175 FLINTKOTE AVE., #F & G SE DECISION MADE: 01-DEC-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
ACON LABORATORIES, INC. 510(k) NO: K993317(TRADITIONAL)
ATTN: NORA C.R. YORK PHONE NO : 858-535-2030
11175 FLINTKOTE AVE., #F & G SE DECISION MADE: 01-DEC-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
ACUSON CORP. 510(k) NO: K992631(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST., N.W. SE DECISION MADE: 15-DEC-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACE-OR RETRACTOR
ADVANCED SURGICAL CONCEPTS (ASC) 510(k) NO: K993544(TRADITIONAL)
ATTN: MARY MCNAMARA CULLINANE PHONE NO : 508-643-2237
49 PLAIN STREET SE DECISION MADE: 22-DEC-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATR 3000, ATR 2000, IMPLANT-PRO
ADVANCED TECHNOLOGY RESEARCH S.A.S510(k) NO: K991401(TRADITIONAL)
ATTN: CAROL A PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 15-DEC-99
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AROMATIC AND FLAVORED TONGUE DEPRESSOR
AGA PLASTIC IND. COM. LTDA. 510(k) NO: K992995(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 09-DEC-99
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: SIMPLIFY D-DIMER, MODEL DCGK1
AGEN BIOMEDICAL LTD. 510(k) NO: K993276(TRADITIONAL)
ATTN: RUSSEL RICHARDS PHONE NO : 617 337 06300
7 & 11 DURBELL ST., SE DECISION MADE: 14-DEC-99
ACACIA RIDGE 510(k) STATEMENT
BRISBANE, AUSTRALIA 4110
DEVICE: VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
AGILENT TECHNOLOGIES, INC. 510(k) NO: K993907(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3176
3000 MINUTEMAN RD. SE DECISION MADE: 06-DEC-99
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALATECH LATEX CONDOM
ALATECH, LLC 510(k) NO: K993887(ABBREVIATED)
ATTN: WAYNE L GAINEY PHONE NO : 334-886-9337
595 EAST LAWRENCE HARRIS HWY SE DECISION MADE: 20-DEC-99
SLOCOMB, AL 36375 510(k) STATEMENT
DEVICE: AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K993833(SPECIAL)
ATTN: SHARON ROBBINS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. SE DECISION MADE: 10-DEC-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-
ALTHIN MEDICAL, INC. 510(k) NO: K990643(TRADITIONAL)
ATTN: AMAURY SANCHEZ PHONE NO : 305-823-5240
14620 N.W. 60TH AVE. SE DECISION MADE: 07-DEC-99
MIAMI LAKES, FL 33014-9308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJ
AMERICAN BIO MEDICA CORP. 510(k) NO: K993796(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 800-227-1243
300 FAIRVIEW AVE. SE DECISION MADE: 21-DEC-99
HUDSON, NY 12534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANTABLE CLIP FOR GENERAL SURGERY
APPLIED MEDICAL RESOURCES 510(k) NO: K993135(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104 SE DECISION MADE: 01-DEC-99
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETERAL ACCESS SHEATH SET - NEW MODELS
APPLIED MEDICAL RESOURCES 510(k) NO: K993650(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-582-6243
26051 MERIT CIRCLE, #104 SE DECISION MADE: 28-DEC-99
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
ARNOLD & RICHTER CINE TECHNIK 510(k) NO: K993283(TRADITIONAL)
ATTN: THOMAS POPP PHONE NO : 49 89 38091289
89 TURKENSTRASSE SE DECISION MADE: 29-DEC-99
MUNICH, GERMANY 80799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLATELETWORKS
ARRAY MEDICAL, INC. 510(k) NO: K990398(TRADITIONAL)
ATTN: DAVID CARVILLE PHONE NO : 908-707-8872
ONE HARVARD WAY, SUITE 5 SE DECISION MADE: 01-DEC-99
HILLSBOROUGH CAMPUS 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH. POWERCORD,
ARTHROCARE CORP. 510(k) NO: K992581(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 09-DEC-99
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVL OPTI CRITICAL CARE ANALYZER
AVL SCIENTIFIC CORP. 510(k) NO: K993837(TRADITIONAL)
ATTN: RANDY BYRD PHONE NO : 770-576-5000
235 HEMBREE PARK DR. SE DECISION MADE: 16-DEC-99
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
AXIS 510(k) NO: K992502(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751
PO BOX 262069 SE DECISION MADE: 21-DEC-99
SAN DIEGO, CA 92196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
BAYER CORP. 510(k) NO: K993309(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 06-DEC-99
MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNO
BAYER CORP. 510(k) NO: K993353(TRADITIONAL)
ATTN: GABRIEL J MURACA JR PHONE NO : 914-631-8000
511 BENEDICT AVE. SE DECISION MADE: 06-DEC-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE
BAYER CORP. 510(k) NO: K993571(TRADITIONAL)
ATTN: THOMAS F FLYNN PHONE NO : 508-359-3877
63 NORTH ST. SE DECISION MADE: 16-DEC-99
MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DI
BAYER CORP. 510(k) NO: K993711(TRADITIONAL)
ATTN: GABRIEL MURACA PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 16-DEC-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/C
BECTON DICKINSON MICROBIOLOGY SYST510(k) NO: K993577(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 01-DEC-99
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LA
BESGLOVE MEDICARE SDN. BHD. 510(k) NO: K993500(TRADITIONAL)
ATTN: LEE AIK LIM PHONE NO : 603 825 6361/2
LOT 6, JALAN P/2A SE DECISION MADE: 02-DEC-99
BANGI INDUSTRIAL ESTATE 510(k) STATEMENT
KAJANG,SELANGOR DARUL,EHASAN, MALAYSIA 43000
DEVICE: MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K994149(SPECIAL)
ATTN: NORMAN E BRUNNER PHONE NO : 800-323-8326
ONE BIO-LOGIC PLAZA SE DECISION MADE: 27-DEC-99
MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-RAD HOMOCYSTEINE BY HPLC
BIO-RAD LABORATORIES, INC. 510(k) NO: K993107(TRADITIONAL)
ATTN: PATRICIA M KLIMLEY PHONE NO : 510-741-6263
4000 ALFRED NOBEL DR. SE DECISION MADE: 21-DEC-99
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
BIO-RESEARCH ASSOCIATES, INC. 510(k) NO: K991756(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 219-267-6639
4113 NORTH PORT WASHINGTON RD. SE DECISION MADE: 10-DEC-99
MILWAUKEE, WI 53212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEI
BIOGRAFIK (MALAYSIA) SDN BHD 510(k) NO: K993529(TRADITIONAL)
ATTN: SHUKUR BIN HASRAN PHONE NO : 067 993 6453646449
PT 3307 JALAN AM 1 SE DECISION MADE: 29-DEC-99
ARAB-MALAYSIAN INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
NILAI, NEGERI SEMBILAN, MALAYSIA 71800
DEVICE: BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
BIOMAGNETIC TECHNOLOGIES, INC. 510(k) NO: K993708(SPECIAL)
ATTN: EUGENE C HIRSCHKOFF PHONE NO : 858-463-6300
9727 PACIFIC HEIGHTS BLVD. SE DECISION MADE: 03-DEC-99
SAN DIEGO, CA 92121-3719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAY GC
BIOMED DIAGNOSTICS, INC. 510(k) NO: K993033(TRADITIONAL)
ATTN: ROBERT D HALL PHONE NO : 408-451-0400
1430 KOLL CIRCLE, SUITE 101 SE DECISION MADE: 16-DEC-99
SAN JOSE, CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSORB TRAUMA PLATING SYSTEM
BIOMET, INC. 510(k) NO: K992355(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 20-DEC-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: TITANIUM PEDIATRIC FEMORAL NAIL
BIOMET, INC. 510(k) NO: K993956(SPECIAL)
ATTN: LONNIE WITHAM PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 20-DEC-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580
DEVICE: MODULAR REACH HIP
BIOMET, INC. 510(k) NO: K994038(SPECIAL)
ATTN: FRED MCCLURE PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 22-DEC-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIONIKE AQ PHENCYCLIDINE (PCP) TEST
BIONIKE LABORATORIES, INC. 510(k) NO: K993945(TRADITIONAL)
ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223
1420 LOS ANGELES AVE SE DECISION MADE: 07-DEC-99
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065
DEVICE: SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 2
BIONX IMPLANTS, LTD. 510(k) NO: K993073(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 06-DEC-99
HERMINKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
BIONX IMPLANTS, LTD. 510(k) NO: K993074(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 10-DEC-99
HERMINKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: MODIFICATION TO CARTO EP NAVIGATION SYSTEM
BIOSENSE WEBSTER, INC. 510(k) NO: K993729(SPECIAL)
ATTN: SANDRA WILLIAMSON PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD. SE DECISION MADE: 03-DEC-99
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQUE A.V. FISTULA NEEDLE SET
BIOTEQUE CORP. 510(k) NO: K993118(TRADITIONAL)
ATTN: ALLEN REICH PHONE NO : 520-773-9488
900 N. SWITZER CANYON DR. #142 SE DECISION MADE: 17-DEC-99
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
BIOTRONIK, INC. 510(k) NO: K993139(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 17-DEC-99
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIRD V.I.P. GOLD/STERLING
BIRD PRODUCTS CORP. 510(k) NO: K993449(SPECIAL)
ATTN: DARRYL SHELBY PHONE NO : 800-232-7633
1100 BIRD CENTER DR. SE DECISION MADE: 20-DEC-99
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTITAK SS
BONUTTI RESEARCH, INC. 510(k) NO: K993115(TRADITIONAL)
ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412
2600 SOUTH RANEY SE DECISION MADE: 17-DEC-99
P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA
EFFINGHAM, IL 62401
DEVICE: WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTE
BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K993232(TRADITIONAL)
ATTN: RONALD W BENNETT PHONE NO : 612-694-5642
5905 NATHAN LANE SE DECISION MADE: 30-DEC-99
MINNEAPOLIS, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUGLIELMI DETACHABLE (GDC)
BOSTON SCIENTIFIC, TARGET 510(k) NO: K991139(TRADITIONAL)
ATTN: JIM LEATHLEY PHONE NO : 510-440-7836
47900 BAYSIDE PARKWAY SE DECISION MADE: 22-DEC-99
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARDEX I.C. PEDIATRIC FOLEY CATHETER
C.R. BARD, INC. 510(k) NO: K993464(ABBREVIATED)
ATTN: GEORGIA C ABERNATHY PHONE NO : 770-784-6454
8195 INDUSTRIAL BLVD. SE DECISION MADE: 10-DEC-99
COVINGTON, GA 30209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG-7000DX ECG RECORDER/TRANSMITTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K993799(SPECIAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 10-DEC-99
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG-2100 ECG TRANSMITTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K994009(SPECIAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 21-DEC-99
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE ANALYZER
CARESIDE, INC. 510(k) NO: K993634(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 02-DEC-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE DIRECT BILIRUBIN
CARESIDE, INC. 510(k) NO: K993771(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 27-DEC-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST RESPONSE 1-STEP PREGNANCY
CARTER-WALLACE, INC. 510(k) NO: K992232(TRADITIONAL)
ATTN: MAUREEN GARNER PHONE NO : 800-619-6344
HALF ACRE RD. SE DECISION MADE: 21-DEC-99
P.O. BOX 1001 510(k) SUMMARY AVAILABLE FROM FDA
CRANBURY, NJ 08512
DEVICE: QMS MAPPING SYSTEM,MODEL 2000
CATHDATA INC. 510(k) NO: K990058(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 15-DEC-99
STAMPFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHETER INNOVATIONS IMPLANTABLE PORT
CATHETER INNOVATIONS, INC. 510(k) NO: K993860(SPECIAL)
ATTN: ROGER L RICHINS PHONE NO : 801-954-8444
3598 WEST 1820 SOUTH SE DECISION MADE: 03-DEC-99
SALT LAKE CITY, UT 84104-4859 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
CLINICAL DIAGNOSTIC SOLUTIONS, INC510(k) NO: K993375(ABBREVIATED)
ATTN: COLIN ALDERSLEY PHONE NO : 954-791-1773
1660 N.W. 65TH AVE., SUITE 2 SE DECISION MADE: 20-DEC-99
PLANTATION, FL 33313 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR
COBE CARDIOVASCULAR, INC. 510(k) NO: K993001(TRADITIONAL)
ATTN: LYNN LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 03-DEC-99
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K993304(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111
PENTLANDS SCIENCE PARK SE DECISION MADE: 06-DEC-99
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
COLTENE/WHALEDENT INC. 510(k) NO: K993255(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000
750 CORPORATE DR. SE DECISION MADE: 06-DEC-99
MAHWAH, NJ 07430-2009 510(k) STATEMENT
DEVICE: MODIFICATION OF PARAPOST CEMENT
COLTENE/WHALEDENT INC. 510(k) NO: K993710(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000
750 CORPORATE DR. SE DECISION MADE: 21-DEC-99
MAHWAH, NJ 07430-2009 510(k) STATEMENT
DEVICE: PARAPOST SYSTEM STERILIZABLE ORGANIZER
COLTENE/WHALEDENT INC. 510(k) NO: K993835(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000
750 CORPORATE DR. SE DECISION MADE: 16-DEC-99
MAHWAH, NJ 07430-2009 510(k) STATEMENT
DEVICE: EMBOLIZATION COIL SYSTEM
COOK, INC. 510(k) NO: K992121(TRADITIONAL)
ATTN: LISA WEBB PHONE NO : 812-339-2235
925 S. CURRY PIKE SE DECISION MADE: 20-DEC-99
BLOOMINGTON, IN 47401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K994068(SPECIAL)
ATTN: ELENA JUGO PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 23-DEC-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
DADE BEHRING, INC. 510(k) NO: K993299(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-636-7727
1851 DELAWARE PKWY. SE DECISION MADE: 07-DEC-99
MIAMI, FL 33125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTREP PLUS PANEL
DADE MICROSCAN, INC. 510(k) NO: K983746(TRADITIONAL)
ATTN: SHAROLYN J LENTSCH PHONE NO : 916-374-3183
1584 ENTERPRISE BLVD. SE DECISION MADE: 09-DEC-99
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRIED GRAM-POSITIVE MIC/COMBO PANELS
DADE MICROSCAN, INC. 510(k) NO: K993102(TRADITIONAL)
ATTN: TREVOR WALL PHONE NO : 916-374-3332
1584 ENTERPRISE BLVD. SE DECISION MADE: 02-DEC-99
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
DANEK MEDICAL, INC. 510(k) NO: K993855(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 15-DEC-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIP TONOMETRY CATHETER, 14F
DATEX-OHMEDA, INC. 510(k) NO: K993296(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 978-640-0460
3 HIGHWOOD DR. SE DECISION MADE: 15-DEC-99
TEWKSBURY, MA 01876 510(k) STATEMENT
DEVICE: ENIGMA HI-BASE DENTURE BASE MATERIAL
DAVIS SCHOTTLANDER & DAVIS, LTD. 510(k) NO: K993717(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE SE DECISION MADE: 22-DEC-99
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: MODIFICATION TO ISOLA SPINAL SYSTEM
DEPUY ACROMED 510(k) NO: K993030(TRADITIONAL)
ATTN: FRANK MAAS PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 29-DEC-99
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREMER HALO SYSTEM TITANIUM SKULL PIN
DEPUY ACROMED 510(k) NO: K993099(TRADITIONAL)
ATTN: FRANK MASS PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 15-DEC-99
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K993952(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 16-DEC-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
DIASORIN INC. 510(k) NO: K992552(TRADITIONAL)
ATTN: JUDITH J SMITH PHONE NO : 301-497-0005
9175 GUIFORD ROAD SE DECISION MADE: 16-DEC-99
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
DIASORIN/AMERICAN STANDARD COMPANI510(k) NO: K994110(SPECIAL)
ATTN: JUDITH J SMITH PHONE NO : 301-497-0005
9175 GUILFORD RD., SUITE 100 SE DECISION MADE: 21-DEC-99
QUARRY PARK PLACE 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21046
DEVICE: DIGITEC TWO STAGE COMPRESSION KIT
DIGITEC MEDICAL SERVICE CORPORATIO510(k) NO: K993681(TRADITIONAL)
ATTN: JAMES J MCGINITY PHONE NO : 770-995-0050
465 MALTBIE STREET SE DECISION MADE: 21-DEC-99
SUITE 407 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCEVILLE, GA 30045
DEVICE: DISETRONIC D-TRON INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS 510(k) NO: K994186(SPECIAL)
ATTN: LEE LEICHTER PHONE NO : 941-768-1118
7690 CAMERON CIRCLE SE DECISION MADE: 30-DEC-99
FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISENTRONIC PENFINE INJECTION PEN NEEDLE
DISETRONIC MEDICAL SYSTEMS 510(k) NO: K994197(SPECIAL)
ATTN: LEE LEICHTER PHONE NO : 941-768-1118
7690 CAMERON CIRCLE SE DECISION MADE: 29-DEC-99
FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200
DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K991714(TRADITIONAL)
ATTN: RICHARD DESLAURIERS PHONE NO : 203-879-9422
143 WOLCOTT RD. SE DECISION MADE: 10-DEC-99
WOLCOTT, CT 510(k) STATEMENT
DEVICE: CUSTODIOL
DR. FRANZ KOHLER CHEMIE GMBH 510(k) NO: K992209(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 10-DEC-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
DRUG DETECTION DEVICES, LTD. 510(k) NO: K992949(TRADITIONAL)
ATTN: BRUCE CHRISTIE PHONE NO : 770-886-6226
6820 MEADOWRIDGE COURT SE DECISION MADE: 27-DEC-99
SUITE A-7 510(k) SUMMARY AVAILABLE FROM FDA
ALPHARETTA, GA 30005
DEVICE: ETHYL CHLORIDE DISPENSER
DUKAL CORP. 510(k) NO: K984564(TRADITIONAL)
ATTN: ED RASOM PHONE NO : 813-376-4154
3234 ELLA LANE SE DECISION MADE: 02-DEC-99
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
EBI, L.P. 510(k) NO: K993822(SPECIAL)
ATTN: PATRICIA FLOOD PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 10-DEC-99
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX VISION FIXATION SYSTEM
EBI, L.P. 510(k) NO: K993886(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 14-DEC-99
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSITE 3000 SYSTEM
ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K992479(TRADITIONAL)
ATTN: JAMES W BULLOCK PHONE NO : 651-523-6928
1350 ENERGY LN., SUITE 110 SE DECISION MADE: 02-DEC-99
ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT-SHELL DISPOSABLE SPO2 SENSOR
EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K992092(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-801-9854
1800 10TH ST., SUITE 300 SE DECISION MADE: 22-DEC-99
PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPO2 WRAP SENSOR
EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K992211(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-801-9854
1800 10TH ST., SUITE 300 SE DECISION MADE: 22-DEC-99
PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMPTFLOW
ESPE DENTAL AG 510(k) NO: K993566(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 06-DEC-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5,
ETHICON ENDO-SURGERY, INC. 510(k) NO: K993054(TRADITIONAL)
ATTN: RUTH ANN WOOD PHONE NO : 513-483-3468
4545 CREEK RD. SE DECISION MADE: 09-DEC-99
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "POLLER CALIBRANTS"
EUROPEAN CONCERTED ACTION ON ANTIC510(k) NO: K991439(TRADITIONAL)
ATTN: L. POLLER PHONE NO : 441 612 755516
OXFORD ROAD SE DECISION MADE: 20-DEC-99
MANCHESTER, UNITED KINGDOM M13 9PT510(k) STATEMENT
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN L
FELDA RUBBER CORP. 510(k) NO: K993820(TRADITIONAL)
ATTN: YUNUS LATIF PHONE NO : 03 292 3033
TINGKAT 7, BALAI FELDA SE DECISION MADE: 02-DEC-99
JALAN GURNEY 1 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 54000
DEVICE: LATEX SURGICAL GLOVES, PRE-POWDERED
FITCO DIPPED PRODUCTS PVT. LTD 510(k) NO: K993450(TRADITIONAL)
ATTN: JOSEPH PEREIRA PHONE NO : 910 484 424033
14-A COCHIN EXPORT PROCESSING SE DECISION MADE: 29-DEC-99
ZONE, KAKKANAND, COCHIN 510(k) SUMMARY AVAILABLE FROM FDA
KERALA, INDIA 682 030
DEVICE: FRIALIT-2 SELECT COMPONENTS
FRIADENT GMBH 510(k) NO: K993095(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 09-DEC-99
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K993645(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414 SE DECISION MADE: 21-DEC-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435
GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K994075(TRADITIONAL)
ATTN: JOHN BOTTJER PHONE NO : 949-240-7584
24040 CAMINO DEL AVION, A-195 SE DECISION MADE: 27-DEC-99
MONARCH BEACH, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIM-107 PREP-CHECK
GENERAL DEVICES 510(k) NO: K993202(TRADITIONAL)
ATTN: MICHAEL SMITH PHONE NO : 201-313-7075
1000 RIVER ST. SE DECISION MADE: 17-DEC-99
RIDGEFIELD, NJ 07657 510(k) STATEMENT
DEVICE: GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PR
GLOVCO (M) SDN. BHD. 510(k) NO: K993752(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 391 13888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 03-DEC-99
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
GLOVESWORLD INDUSTRIES SDN. BHD. 510(k) NO: K993127(TRADITIONAL)
ATTN: BIEN LONG NIEN PHONE NO : 603 816 7567/7568
LOT P.T. 153, KAWASAN SE DECISION MADE: 02-DEC-99
PERUSAHAAN BERANANG, MUKIM 510(k) STATEMENT
BERANANG, SELANGOR, D.E., MALAYSIA 43700
DEVICE: GRADILEIDEN V TEST
GRADIPORE LTD. 510(k) NO: K992456(TRADITIONAL)
ATTN: RHONDA PILGRIM PHONE NO : 800 762 2620
LOT16 RIVERSIDE CORPORATE PARK SE DECISION MADE: 21-DEC-99
35-105 DELHI ROAD 510(k) SUMMARY AVAILABLE FROM FDA
NORTH RYDE, AUSTRALIA NSW 2113
DEVICE: LATEX EXAMINATION POWDERED GLOVES
GREAT GLOVE SDN BHD 510(k) NO: K993386(TRADITIONAL)
ATTN: K.M. LEE PHONE NO : 603 350 0646
24, JALAN MOKHTAR DUA SE DECISION MADE: 20-DEC-99
KAPAR, SELANGOR D.E., MALAYSIA 422510(k) STATEMENT
DEVICE: FASTSEAL CHEST WOUND DRESSING
GREENFIELD MEDICAL TECHNOLOGIES, I510(k) NO: K990079(TRADITIONAL)
ATTN: DONALD R GORSUCH PHONE NO : 508-393-7907
40 VALENTINE ROAD SE DECISION MADE: 23-DEC-99
NORTHBOROUGH, MA 01532 510(k) STATEMENT
DEVICE: EIS THREADED SCREW FRACTURE FIXATION
GROUPE LEPINE 510(k) NO: K991964(TRADITIONAL)
ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882
962 SOUTH TAMIAMI TRAIL SE DECISION MADE: 20-DEC-99
SUITE 203 510(k) STATEMENT
SARASOTA, FL 34326
DEVICE: GYRUS HYSTEROSCOPIC RESECTOSCOPE
GYRUS MEDICAL LTD. 510(k) NO: K993749(SPECIAL)
ATTN: DAVID KAY PHONE NO : 440 122 2300100
FORTRAN RD., ST. MELLONS SE DECISION MADE: 03-DEC-99
CARDIFF, UNITED KINGDOM CF3 0LT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
GYRUS MEDICAL LTD. 510(k) NO: K994166(SPECIAL)
ATTN: DAVID KAY PHONE NO : 440 122 23000100
FORTRAN RD., ST. MELLONS SE DECISION MADE: 27-DEC-99
CARDIFF, UNITED KINGDOM CF3 0LT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPO
HARDY DIAGNOSTICS 510(k) NO: K993812(TRADITIONAL)
ATTN: MELISSA M TAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 21-DEC-99
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK AMIKACIN 30MCG
HARDY DIAGNOSTICS 510(k) NO: K993993(TRADITIONAL)
ATTN: MELISSA M TRAYLOR, RAC PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 27-DEC-99
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK AZITHROMYCIN 15MCG
HARDY DIAGNOSTICS 510(k) NO: K993994(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 21-DEC-99
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: LC COMPOSITE
HARRY J. BOSWORTH CO. 510(k) NO: K991492(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 02-DEC-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
HARRY J. BOSWORTH CO. 510(k) NO: K993716(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 21-DEC-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: HL148 & HL168
HEALTH & LIFE CO., LTD. 510(k) NO: K990807(TRADITIONAL)
ATTN: SUSAN CHEN PHONE NO : 886 232 349600
4F-3, NO. 351, CHUNG SHAM RD. SE DECISION MADE: 03-DEC-99
SEC.02, CHUNG HO CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
HELAX AB 510(k) NO: K993766(SPECIAL)
ATTN: E.S. MARTELL PHONE NO : 011 461 85655000
447 MARCH ROAD SE DECISION MADE: 08-DEC-99
KANATA ONTARIO, CANADA K2K 1X8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOCHEM-HT SYSTEM
HEMOCLEANSE, INC. 510(k) NO: K993330(TRADITIONAL)
ATTN: STEPHEN R ASH PHONE NO : 765-463-9540
2700 KENT AVE. SE DECISION MADE: 30-DEC-99
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-VISION FILL
HERAEUS KULZER, INC. 510(k) NO: K993602(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 15-DEC-99
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: SOLITAIRE 2
HERAEUS KULZER, INC. 510(k) NO: K993932(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-291-0661
4315 S. LAFAYETTE BLVD. SE DECISION MADE: 22-DEC-99
SOUTH BEND, IN 46530 510(k) STATEMENT
DEVICE: HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3
HEWLETT-PACKARD CO. 510(k) NO: K992977(TRADITIONAL)
ATTN: WARREN R WALTERS PHONE NO : 515-244-1212
2500 BELL AVE. SE DECISION MADE: 01-DEC-99
DES MOINES, IA 50321 510(k) STATEMENT
DEVICE: MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER,
HEWLETT-PACKARD CO. 510(k) NO: K993169(TRADITIONAL)
ATTN: SHEILA W PICKERING, PHD. PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE SE DECISION MADE: 20-DEC-99
LOS ALTOS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-S
HEWLETT-PACKARD GMBH 510(k) NO: K992595(SPECIAL)
ATTN: EGON PFEIL PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140 SE DECISION MADE: 08-DEC-99
BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
HOWMEDICA OSTEONICS CORP. 510(k) NO: K990849(TRADITIONAL)
ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376
359 VETERANS BLVD. SE DECISION MADE: 20-DEC-99
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993402(TRADITIONAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 20-DEC-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON INSET PATELLA, 25MM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993692(SPECIAL)
ATTN: TERRY SHERIDAN POWELL PHONE NO : 201-934-4375
59 ROUTE 17 SE DECISION MADE: 02-DEC-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIFRESH 400 LENS
HYDRON LTD. 510(k) NO: K983637(TRADITIONAL)
ATTN: JULIAN B HOLLOWAY PHONE NO : 011 441 252554500
HAWLEY LANE SE DECISION MADE: 10-DEC-99
FARNBOROUGH, HANTS, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNN FLUORO NAVIGATION SYSTEM
I.S.G. TECHNOLOGIES, INC. 510(k) NO: K993673(TRADITIONAL)
ATTN: DOLORES MCGIRR PHONE NO : 905 672 2100
6509 AIRPORT RD. SE DECISION MADE: 21-DEC-99
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
IBM ISRAEL LTD. 510(k) NO: K993338(TRADITIONAL)
ATTN: ELI M ORBACH PHONE NO : 972 299 32768
P.O. BOX 6718 SE DECISION MADE: 29-DEC-99
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BI
IMAGYN SURGICAL 510(k) NO: K993936(TRADITIONAL)
ATTN: JULIE POWELL PHONE NO : 616-629-5811
8850 M-89 SE DECISION MADE: 27-DEC-99
RICHLAND, MI 49083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLON ALERT TEST
IMMUNOSTICS, INC. 510(k) NO: K992759(TRADITIONAL)
ATTN: VINCENT P LASTELLA PHONE NO : 732-918-0770
3505 SUNSET AVE. SE DECISION MADE: 06-DEC-99
OCEAN, NJ 07712 510(k) STATEMENT
DEVICE: DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3
IMPAX TECHNOLOGY INC. 510(k) NO: K993532(TRADITIONAL)
ATTN: PAULA PFEIFLE PHONE NO : 519 746 2900
455 PHILLIP ST. SE DECISION MADE: 15-DEC-99
WATERLOO, ONTARIO, CANADA N2L 3X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVIGRA
INDUS MEDICARE LTD. 510(k) NO: K993693(ABBREVIATED)
ATTN: P.K. REDDY PHONE NO : 91 40 7760241
144, S.P. RD., BEGUMPET SE DECISION MADE: 29-DEC-99
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT
DEVICE: INNOVAQUARTZ GENERAL SHAPE LASER FIBER
INNNOVAQUARTZ INC. 510(k) NO: K994010(TRADITIONAL)
ATTN: RANDY MCLELLAN PHONE NO : 602-268-4930
4420 SOUTH 32ND ST. SE DECISION MADE: 17-DEC-99
PHOENIX, AZ 85040 510(k) STATEMENT
DEVICE: ABSOLUTE ABSORBABLE INTERFERENCE SCREW
INNOVASIVE DEVICES, INC. 510(k) NO: K993975(SPECIAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-460-8229
734 FOREST ST. SE DECISION MADE: 20-DEC-99
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,
INTERPORE CROSS INTL. 510(k) NO: K993808(SPECIAL)
ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 06-DEC-99
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
INTRACEL CORP. 510(k) NO: K991074(TRADITIONAL)
ATTN: SHERYL RUPPEL PHONE NO : 301-258-5200
1330 PICCARD DR. SE DECISION MADE: 21-DEC-99
ROCKVILLE, MD 20850-4396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRALASE 600C LASER KERATOME
INTRALASE CORPORATION 510(k) NO: K993153(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
18732 SAGINAW SE DECISION MADE: 17-DEC-99
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE C
INVACARE CORP. 510(k) NO: K993413(TRADITIONAL)
ATTN: EDWAED A KROLL PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 15-DEC-99
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036
DEVICE: IRIDERM, MODEL APEX 800
IRIDEX CORP. 510(k) NO: K992298(TRADITIONAL)
ATTN: BRAD RENTON PHONE NO : 650-962-8100
1212 TERRA BELLA AVE. SE DECISION MADE: 09-DEC-99
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMA-CATH STEERABLE EP CATHETERS
IRVINE BIOMEDICAL, INC. 510(k) NO: K991878(TRADITIONAL)
ATTN: ROGER TU PHONE NO : 949-851-3053
2146-A MICHELSON DR. SE DECISION MADE: 10-DEC-99
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYRODE'S SOLUTION-ACIDIFIED
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991339(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 06-DEC-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TETRIC FLOW
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K993783(TRADITIONAL)
ATTN: PETER P MANCUSO PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 13-DEC-99
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: K-ASSAY FIBRINOGEN
KAMIYA BIOMEDICAL CO. 510(k) NO: K993482(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 06-DEC-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY MULTI-ANALYTE CALIBRATOR
KAMIYA BIOMEDICAL CO. 510(k) NO: K993853(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 27-DEC-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: DCI ENDOSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K993539(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 15-DEC-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KEELER CRYO MASTER & PROBES
KEELER INSTRUMENTS, INC. 510(k) NO: K992954(TRADITIONAL)
ATTN: EUGENE R VAN ARSDALE PHONE NO : 800-523-5620
456 PARKWAY SE DECISION MADE: 21-DEC-99
BROOMALL, PA 19008 510(k) STATEMENT
DEVICE: KLS-MARTIN MMF SCREW
KLS-MARTIN L.P. 510(k) NO: K980760(TRADITIONAL)
ATTN: PATRICK J LAMB PHONE NO : 813-376-4154
3234 ELLA LANE SE DECISION MADE: 21-DEC-99
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
LAERDAL MEDICAL A/S 510(k) NO: K993668(TRADITIONAL)
ATTN: MAGNE STEINSET PHONE NO : 47 515 11700
TANKE SVILANDSGT. 30 SE DECISION MADE: 20-DEC-99
STAVANGER, NORWAY N 4001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONIT
LIFESTREAM TECHNOLOGIES, INC. 510(k) NO: K993096(TRADITIONAL)
ATTN: JACKSON B CONNOLLY PHONE NO : 208-457-9409
51O CLEARWATER LOOP, SUITE 101 SE DECISION MADE: 20-DEC-99
POST FALLS, ID 83854 510(k) STATEMENT
DEVICE: ENDOPEARL WITH THREADER
LINVATEC CORP. 510(k) NO: K993339(TRADITIONAL)
ATTN: LAURA SENEFF PHONE NO : 727-392-6464
11311 CONCEPT BLVD. SE DECISION MADE: 10-DEC-99
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-PACT CORNEAL LIGHT SHIELD
M-PACT CORP. 510(k) NO: K993883(TRADITIONAL)
ATTN: AL BOEDEKER PHONE NO : 785-542-2920
1040 0CL PARKWAY, SE DECISION MADE: 21-DEC-99
EUDORA, KS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
MAERSK MEDICAL A/S 510(k) NO: K990110(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
MAERSK MEDICAL A/S 510(k) NO: K990111(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
MAERSK MEDICAL A/S 510(k) NO: K990112(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 45
MAERSK MEDICAL A/S 510(k) NO: K990113(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
MAERSK MEDICAL A/S 510(k) NO: K990115(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONI
MAGNETIC RESONANCE EQUIPMENT CORP.510(k) NO: K983250(TRADITIONAL)
ATTN: G.RONALD MORRIS PHONE NO : 516-243-3500
6 WASHINGTON AVE. SE DECISION MADE: 12-DEC-99
BAY SHORE, NY 11706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTISTAR MR INJECTOR SYSTEM
MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K984088(TRADITIONAL)
ATTN: BRIDGET DRAKE PHONE NO : 800-347-9730
2111 EAST GALBRAITH RD. SE DECISION MADE: 06-DEC-99
P.O. BOX 156305 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45215-6305
DEVICE: QUANTITATIVE SENTINEL SYSTEM
MARQUETTE MEDICAL SYSTEMS, INC. 510(k) NO: K993008(TRADITIONAL)
ATTN: MARIA VITUG FOUTS PHONE NO : 800-851-6525
200 HARRY SOUTH TRUMAN PKWY. SE DECISION MADE: 06-DEC-99
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
ANNAPOLIS, MD 21401
DEVICE: CERADIUM V NON-PRECIOUS CERAMIC ALLOY
MATECH, INC. 510(k) NO: K993572(TRADITIONAL)
ATTN: PAUL L SAXTON PHONE NO : 818-367-2472
13010 SAN FERNANDO RD. SE DECISION MADE: 13-DEC-99
SYLMAR, CA 91342 510(k) STATEMENT
DEVICE: SYSTEM 2100
MATH SOLUTIONS, LLC 510(k) NO: K993530(TRADITIONAL)
ATTN: WENDEL DEAN RENNER PHONE NO : 410-997-9578
5975 GALES LANE SE DECISION MADE: 15-DEC-99
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFINDER II ANGIOGRAPHIC CATHETER
MAXXIM MEDICAL 510(k) NO: K990173(TRADITIONAL)
ATTN: EDDIE MONROE PHONE NO : 903-675-9321
1445 FLAT CREEK RD. SE DECISION MADE: 21-DEC-99
ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE DOPPLER ULTRASOUND SYSTEM
MEDASONICS, INC. 510(k) NO: K991441(TRADITIONAL)
ATTN: WILLIAM E MCKAY PHONE NO : 801-944-9977
9712 S. ALTAMONT DRIVE SE DECISION MADE: 28-DEC-99
SANDY, UT 84092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIT ENHANCER
MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K992943(TRADITIONAL)
ATTN: LINDA M UPTON PHONE NO : 510-357-3952
14477 CATALINA ST. SE DECISION MADE: 10-DEC-99
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
MEDIPACK - MEDICAL PACKAGING MFG. 510(k) NO: K993764(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-519-1098
9109 COPENHAVER DRIVE SE DECISION MADE: 16-DEC-99
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K993761(TRADITIONAL)
ATTN: DOUGLAS F ORR PHONE NO : 203-438-5588
109 DANBURY ROAD SE DECISION MADE: 28-DEC-99
RIDGEFIELD, CT 06877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERDICT -II OPIATES 2000
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K992111(TRADITIONAL)
ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 16-DEC-99
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
MEMCATH TECHNOLOGIES LLC 510(k) NO: K993226(TRADITIONAL)
ATTN: MARC JAKER PHONE NO : 651-450-7400
1777 OAKDALE AVENUE SE DECISION MADE: 10-DEC-99
WEST ST. PAUL, MN 55118-4031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENTOR EVACARE VAGINAL PESSARIES
MENTOR CORP. 510(k) NO: K993308(TRADITIONAL)
ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304
201 MENTOR DRIVE SE DECISION MADE: 13-DEC-99
SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER TOXINS A&B, MODEL 616096
MERIDIAN DIAGNOSTICS, INC. 510(k) NO: K993914(SPECIAL)
ATTN: DAVID H WILLIS PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 10-DEC-99
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTAPAL, ALLOY NO. 5161
METALOR DENTAL USA CORP. 510(k) NO: K993474(TRADITIONAL)
ATTN: KENNETH A PUTNEY PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 02-DEC-99
NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT
DEVICE: AUROFLUID M, ALLOY NO. 5315
METALOR DENTAL USA CORP. 510(k) NO: K993475(TRADITIONAL)
ATTN: KENNETH A PUTNEY PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 09-DEC-99
NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT
DEVICE: V-DELTA SPECIAL, ALLOY NO. 5154
METALOR DENTAL USA CORP. 510(k) NO: K993505(TRADITIONAL)
ATTN: KENNITH A PUTNEY PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 08-DEC-99
P.O. BOX 255 510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761
DEVICE: PAGALINOR 4 , ALLOY NO. 5440
METALOR DENTAL USA CORP. 510(k) NO: K993506(TRADITIONAL)
ATTN: KENNETH A PUTNEY PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 08-DEC-99
P.O. BOX 255 510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761
DEVICE: V-SUPRAGOLD, ALLOY NO. 5024
METALOR DENTAL USA CORP. 510(k) NO: K993507(TRADITIONAL)
ATTN: KENNETH A PUTNEY PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 06-DEC-99
P.O. BOX 255 510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761
DEVICE: V-SUPRA PLUS, ALLOY NO. 5025
METALOR DENTAL USA CORP. 510(k) NO: K993508(TRADITIONAL)
ATTN: KENNETH A PUTNEY PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 06-DEC-99
P.O. BOX 255 510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761
DEVICE: VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K993821(SPECIAL)
ATTN: R.H. HOPKINS PHONE NO : 03 977 51234
57 ASTER AVE. SE DECISION MADE: 09-DEC-99
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: TALON ANCHOR SNAP-PAK
MITEK PRODUCTS 510(k) NO: K993261(TRADITIONAL)
ATTN: PAULA A BULGER PHONE NO : 781-251-2746
60 GLACIER DR. SE DECISION MADE: 02-DEC-99
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TALON ANCHOR SNAP-PAK
MITEK PRODUCTS 510(k) NO: K993327(TRADITIONAL)
ATTN: PAULA E BULGER PHONE NO : 781-251-2746
60 GLACIER DR. SE DECISION MADE: 16-DEC-99
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLVE QUICKANCHOR
MITEK PRODUCTS 510(k) NO: K993575(TRADITIONAL)
ATTN: PAULA E BULGER PHONE NO : 781-251-2746
60 GLACIER DR. SE DECISION MADE: 29-DEC-99
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK
MORAX 510(k) NO: K992148(TRADITIONAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
13805 WATERLOO ROAD SE DECISION MADE: 29-DEC-99
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: OBC-300 BREAST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K993776(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 03-DEC-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: QWH-300 WRIST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K993819(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 03-DEC-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: AED ARTHROSCOPE
NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K991656(TRADITIONAL)
ATTN: GAYLE M BUTLER PHONE NO : 310-446-4600
10801 NATIONAL BLVD., #603 SE DECISION MADE: 02-DEC-99
LOS ANGELES, CA 90064 510(k) STATEMENT
DEVICE: AED LAPAROSCOPE
NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K993688(TRADITIONAL)
ATTN: GAYLE M BUTLER PHONE NO : 310-446-4600
10801 NATIONAL BLVD., #603 SE DECISION MADE: 06-DEC-99
LOS ANGELES, CA 90064 510(k) STATEMENT
DEVICE: AED CYSTOSCOPE
NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K993689(TRADITIONAL)
ATTN: GAYLE M BUTLER PHONE NO : 310-446-4600
10801 NATIONAL BLVD., #603 SE DECISION MADE: 15-DEC-99
LOS ANGELES, CA 90064 510(k) STATEMENT
DEVICE: ULTRA-GARMENT ELECTRODE
NEWWAVE MEDICAL LLC 510(k) NO: K993130(TRADITIONAL)
ATTN: ROBERT ARMSTRONG PHONE NO : 972-396-5400
1538 HAVEN PLACE SE DECISION MADE: 17-DEC-99
ALLEN, TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
NEXAN TELEMED LTD. 510(k) NO: K993643(TRADITIONAL)
ATTN: KENNETH PALMER PHONE NO : 301-548-0508
15825 SHADY GROVE ROAD SE DECISION MADE: 28-DEC-99
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850-4008
DEVICE: NEXFLEX TOTAL KNEE SYSTEM
NEXMED, INC. 510(k) NO: K991882(TRADITIONAL)
ATTN: JASON BLAIN PHONE NO : 760-779-8250
42-160 STATE ST., SUITE B SE DECISION MADE: 08-DEC-99
PALM DESERT, CA 92211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K992188(TRADITIONAL)
ATTN: JAMES A RYBSKI PHONE NO : 949-240-5260
33051 CALLE AVIADOR SE DECISION MADE: 06-DEC-99
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181
NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K993890(TRADITIONAL)
ATTN: ROBERT D WAXHAM PHONE NO : 757-365-0978
222 INSTITUTE ST. SE DECISION MADE: 01-DEC-99
SMITHFIELD, VA 23430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPTOR TREATMENT PLANNING SYSTEM
NOMOS CORP. 510(k) NO: K993359(TRADITIONAL)
ATTN: WILLIAM O CHISHKO PHONE NO : 724-934-8200
2591 WEXFORD BAYNE RD., #400 SE DECISION MADE: 21-DEC-99
SEWICKLEY, PA 15143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROL
NOVA BIOMEDICAL CORP. 510(k) NO: K993104(TRADITIONAL)
ATTN: PAUL W MAC DONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 02-DEC-99
WALTHAM, MA 02254-9141 510(k) STATEMENT
DEVICE: UROVIEW 2800
OEC MEDICAL SYSTEMS, INC. 510(k) NO: K993687(ABBREVIATED)
ATTN: TED L PARROT PHONE NO : 801-536-4694
384 WRIGHT BROTHERS DR. SE DECISION MADE: 21-DEC-99
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEST DRAINAGE TUBING
OLSON MEDICAL SALES, INC. 510(k) NO: K993062(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 410-392-7231
2101 COTTONTAIL LANE SE DECISION MADE: 10-DEC-99
SOMERSET, NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNICORDER BIOSCAN SYSTEM
OMNICORDER TECHNOLOGIES, INC. 510(k) NO: K990416(TRADITIONAL)
ATTN: MARK FAUCI PHONE NO : 516-444-6499
25 EAST LOOP RD. SE DECISION MADE: 23-DEC-99
STONY BROOK, NY 11790-3550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNISONIC ENDOSCOPIC DEFLECTOR
OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K993445(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 06-DEC-99
HOPKONTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNISONICS ULTRASONIC PROBES
OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K993628(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 15-DEC-99
HOPKONTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
ORATEC INTERVENTIONS, INC. 510(k) NO: K993854(SPECIAL)
ATTN: SHIELA RAMERMAN PHONE NO : 650-369-9904
3700 HAVEN CT. SE DECISION MADE: 06-DEC-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
ORATEC INTERVENTIONS, INC. 510(k) NO: K993967(SPECIAL)
ATTN: JENNIFER BRENNAN PHONE NO : 650-369-9904
3700 HAVEN CT. SE DECISION MADE: 17-DEC-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT SN
ORGANON TEKNIKA CORP. 510(k) NO: K993421(TRADITIONAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 14-DEC-99
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT SA
ORGANON TEKNIKA CORP. 510(k) NO: K993423(TRADITIONAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 15-DEC-99
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT MP PROCESS BOTTLE
ORGANON TEKNIKA CORP. 510(k) NO: K993576(TRADITIONAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 14-DEC-99
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IM
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K994145(SPECIAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4110
100 INDIGO CREEK DRIVE SE DECISION MADE: 22-DEC-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIAXIAL CONNECTOR
ORTHOTEC, L.L.C. 510(k) NO: K993926(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 17-DEC-99
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: HEMOCHEK-A1C SAMPLE COLLECTION KIT
OSBORN GROUP, INC. 510(k) NO: K990899(TRADITIONAL)
ATTN: GILBERT P BOURK III PHONE NO : 913-390-7146
14901 WEST 117TH STREET SE DECISION MADE: 21-DEC-99
OLATHE, KS 66062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALL SUPOR AEF FILTER
PALL CORP. 510(k) NO: K993379(TRADITIONAL)
ATTN: LEONARD S BERMAN PHONE NO : 516-484-5400
2200 NOTHERN BLVD. SE DECISION MADE: 16-DEC-99
EAST HILLS, NY 11548 510(k) STATEMENT
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINAT
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K993621(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 29-DEC-99
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: PARAGON LENS CARRIER
PARAGON VISION SCIENCES 510(k) NO: K993486(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 22-DEC-99
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAGON LENS VIAL
PARAGON VISION SCIENCES 510(k) NO: K993487(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 22-DEC-99
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCAL MEDICAL AB MENIETT 20
PASCAL MEDICAL AB 510(k) NO: K991562(TRADITIONAL)
ATTN: JEFFREY R SIDEMAN PHONE NO : 612-835-4018
7307 GLOUCHESTER DRIVE SE DECISION MADE: 28-DEC-99
MINNEAPOLIS, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C
PHAMATECH 510(k) NO: K994093(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 16-DEC-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9073
PHAMATECH 510(k) NO: K994219(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9078
PHAMATECH 510(k) NO: K994220(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9068
PHAMATECH 510(k) NO: K994233(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9083
PHAMATECH 510(k) NO: K994234(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9133
PHAMATECH 510(k) NO: K994236(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9063
PHAMATECH 510(k) NO: K994237(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54,
PHARMACIA & UPJOHN CO. 510(k) NO: K993388(TRADITIONAL)
ATTN: KAREN E MATIS PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 01-DEC-99
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS EASYVISION WORKSTATION
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K990329(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7031
710 BRIDGEPORT AVENUE SE DECISION MADE: 07-DEC-99
P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-0917
DEVICE: PHILIPS INTURIS DICOM RECORDER
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K993227(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7031
710 BRIDGEPORT AVE. SE DECISION MADE: 21-DEC-99
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
POINTE SCIENTIFIC, INC. 510(k) NO: K993590(TRADITIONAL)
ATTN: WILLIAM F WALTERS JR. PHONE NO : 313-383-7220
1025 JOHN A. PAPALAS DR. SE DECISION MADE: 21-DEC-99
LINCOLN PARK, MI 48146 510(k) STATEMENT
DEVICE: MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K983860(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE ROAD SE DECISION MADE: 27-DEC-99
INDIANAPOLIS, IN 46268 510(k) STATEMENT
DEVICE: PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
PRIMUS CORP. 510(k) NO: K994045(SPECIAL)
ATTN: JIM NOFFSINGER PHONE NO : 816-523-7491
7235 CENTRAL SE DECISION MADE: 21-DEC-99
KANSAS CITY, MO 64114 510(k) STATEMENT
DEVICE: PRIMUS STEAM STERILIZERS
PRIMUS STERILIZER CO., INC. 510(k) NO: K991575(ABBREVIATED)
ATTN: JEFF REED PHONE NO : 402-344-4200
117 SOUTH 25TH ST. SE DECISION MADE: 03-DEC-99
OMAHA, NE 68131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANUAL BONE MARROW BIOPSY DEVICE
PROMEX, INC. 510(k) NO: K993435(TRADITIONAL)
ATTN: JOSEPH L MARK PHONE NO : 317-736-0128
3062 HUDSON ST. SE DECISION MADE: 06-DEC-99
FRANKLIN, IN 46131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT UNO-DUO
PULPDENT CORP. 510(k) NO: K993683(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 13-DEC-99
WATERTOWN, MA 02471-0780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT
QUALITY LATEX CORP. SDN BHD 510(k) NO: K993271(TRADITIONAL)
ATTN: SHARENE WAN PHONE NO : 605 527 7228
18-20, JALAN KILANG 2, SE DECISION MADE: 02-DEC-99
JELANPANG LIGHT INDUST. ESTATE 510(k) STATEMENT
IPOH, PERAK, MALAYSIA 30100
DEVICE: QUANTECH TOTAL B-HCG ASSAY
QUANTECH LTD. 510(k) NO: K990258(TRADITIONAL)
ATTN: ROBIN HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 21-DEC-99
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELIGHT II HAIR REMOVAL SYSTEM (THE "DELIGHT SYSTEM")
RADIANCY, LTD. 510(k) NO: K992482(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH STREET NW SE DECISION MADE: 27-DEC-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFORMAX MMLC VR1
RADIONICS, INC. 510(k) NO: K993594(SPECIAL)
ATTN: NANCY MACDONALD PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 15-DEC-99
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTD ARM ASSISTIVE ROBOTIC DEVICE
REHABILITATION TECHNOLOGIES DIVISI510(k) NO: K993443(TRADITIONAL)
ATTN: RICHARD M MAHONEY PHONE NO : 973-575-0650
1275 BLOOMFIELD AVENUE SE DECISION MADE: 17-DEC-99
FAIRFIELD, NJ 07004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 3
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K993103(TRADITIONAL)
ATTN: ROBERT L CASARA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 10-DEC-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH
RITA MEDICAL SYSTEMS 510(k) NO: K993944(TRADITIONAL)
ATTN: ERIN DIGNAN-MAZZONE PHONE NO : 650-390-8500
967 NORTH SHORELINE BLVD. SE DECISION MADE: 02-DEC-99
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
ROCAP DIV. OF SABRATEK CORP. 510(k) NO: K990308(TRADITIONAL)
ATTN: AVIA TONEY PHONE NO : 407-855-5104
1629 PRIME CT., SUITE 300 SE DECISION MADE: 10-DEC-99
ORLANDO, FL 32809 510(k) STATEMENT
DEVICE: HEPARIN IV FLUSH SYRINGE, 10 U/ML \
ROCAP DIV. OF SABRATEK CORP. 510(k) NO: K990390(TRADITIONAL)
ATTN: AVIA TONEY PHONE NO : 407-855-5104
1629 PRIME CT., SUITE 300 SE DECISION MADE: 10-DEC-99
ORLANDO, FL 32809 510(k) STATEMENT
DEVICE: ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
ROCHE DIAGNOSTICS CORP. 510(k) NO: K993048(TRADITIONAL)
ATTN: LUANN OCHS PHONE NO : 317-576-7399
9115 HAGUE RD. SE DECISION MADE: 20-DEC-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK SIMPLICITY SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K993829(SPECIAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 09-DEC-99
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K974503(TRADITIONAL)
ATTN: ALEX WESOLOWSKI PHONE NO :
1080 U.S. HIGHWAY 202 SE DECISION MADE: 01-DEC-99
SOMERVILLE, NJ 08876-3711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
ROSSMAX INTL. LTD. 510(k) NO: K993432(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 27835584
2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 20-DEC-99
SECTION 3, NAN KANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
ROSSMAX INTL. LTD. 510(k) NO: K993542(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 278384
2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 29-DEC-99
SECTION 3, NAN KANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: RUSCH BRILLANT SILICONE FOLEY
RUSCH INTL. 510(k) NO: K993063(TRADITIONAL)
ATTN: JULIE A BEAUMONT PHONE NO : 603-532-7706
TALL PINES PARK SE DECISION MADE: 09-DEC-99
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
SC HENNIG ENTERPRISES EUROPE SRL 510(k) NO: K993651(TRADITIONAL)
ATTN: GEORGE O'NEIL PHONE NO :
25 SHANN STREET SE DECISION MADE: 23-DEC-99
FLOREAT PARK 510(k) STATEMENT
WESTERN AUSTRALIA, AUSTRALIA 6014
DEVICE: QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
SERACARE TECHNOLOGY 510(k) NO: K992939(TRADITIONAL)
ATTN: RUSTY SEWELL PHONE NO : 512-445-5100
2170 WOODWARD ST. SE DECISION MADE: 09-DEC-99
AUSTIN, TX 78744-1832 510(k) STATEMENT
DEVICE: QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
SERACARE TECHNOLOGY 510(k) NO: K993631(TRADITIONAL)
ATTN: RUSTY SEWELL PHONE NO : 512-445-5100
2170 WOODWARD ST. SE DECISION MADE: 09-DEC-99
AUSTIN, TX 78744-1832 510(k) STATEMENT
DEVICE: PRE-POWDERED VINYL EXAM GLOVE, NON STERILE
SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K994036(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVE. DE LA D' EMERALD SE DECISION MADE: 20-DEC-99
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAM
SIEMENS CORP. 510(k) NO: K993947(TRADITIONAL)
ATTN: ALICIA JUERGENSEN PHONE NO : 732-321-3243
186 WOOD AVE., SOUTH SE DECISION MADE: 21-DEC-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K993731(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 23-DEC-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
SIGMA DIAGNOSTICS, INC. 510(k) NO: K992711(TRADITIONAL)
ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 06-DEC-99
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
SIGMA DIAGNOSTICS, INC. 510(k) NO: K992712(TRADITIONAL)
ATTN: WILLIAM R GILBERT PHONE NO : 314-286-7835
545 SOUTH EWING AVE. SE DECISION MADE: 06-DEC-99
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND A
SMITH & NEPHEW, INC. 510(k) NO: K993106(ABBREVIATED)
ATTN: JANET JOJNSON GREEN PHONE NO : 901-399-5153
1450 E. BROOKS ROAD SE DECISION MADE: 09-DEC-99
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP
SMITH & NEPHEW, INC. 510(k) NO: K993289(ABBREVIATED)
ATTN: JANET JOHNSON GREEN PHONE NO : 901-399-5153
1450 E. BROOKS ROAD SE DECISION MADE: 20-DEC-99
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
SODEM SYSTEMS 510(k) NO: K994175(SPECIAL)
ATTN: DANIEL BACCINO PHONE NO : 41 227 949696
110 CH. DU PONT DU CENTENAIRE SE DECISION MADE: 21-DEC-99
GENEVA, SWITZERLAND CH-1228 510(k) STATEMENT
DEVICE: SODEM PERFORATOR DRIVE
SODEMSYSTEMS 510(k) NO: K993851(TRADITIONAL)
ATTN: DANIEL BACCINO PHONE NO : 412 279 49696
110, CH. DU PONT-DU-CENTENAIRE SE DECISION MADE: 27-DEC-99
GENEVA, SWITZERLAND, SWITZERLAND C510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITE CUSTOM
SOMA BLUE, INC. 510(k) NO: K993142(TRADITIONAL)
ATTN: JOHN M MITCHELL PHONE NO : 706-821-3600
P.O. BOX 1447 SE DECISION MADE: 27-DEC-99
1025 BROAD STREET 510(k) STATEMENT
AUGUSTA, GA 30903
DEVICE: VITALITY SYSTEM
SOMA BLUE, INC. 510(k) NO: K993143(TRADITIONAL)
ATTN: JOHN M MITCHELL PHONE NO : 706-821-3600
P.O. BOX 1447 SE DECISION MADE: 27-DEC-99
1025 BROAD STREET 510(k) STATEMENT
AUGUSTA, GA 30903
DEVICE: SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM
SONOSITE,INC. 510(k) NO: K994096(TRADITIONAL)
ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297
19807 NORTH CREEK PKWY., #200 SE DECISION MADE: 20-DEC-99
BOTHELL, WA 98011-8214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE SOUNDVASER DISSECTION SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC 510(k) NO: K993868(TRADITIONAL)
ATTN: WILLIAM W CIMINO PHONE NO : 303-926-8608
1300 PLAZA COURT NORTH # 203 SE DECISION MADE: 21-DEC-99
LAFAYETTE, CO 80026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
SPACELABS MEDICAL, INC. 510(k) NO: K981655(TRADITIONAL)
ATTN: NANCY GERTLAR PHONE NO : 425-882-3700
P.O. BOX 97013 SE DECISION MADE: 03-DEC-99
REDMOND, WA 98073-9713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
SPINEOLOGY GROUP, LLC 510(k) NO: K990959(ABBREVIATED)
ATTN: PAMELA SNYDER PHONE NO : 651-351-1011
1815 NORTHWESTERN AVE. SE DECISION MADE: 27-DEC-99
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LA
SRI JOHANI SDN. BHD. 510(k) NO: K993454(TRADITIONAL)
ATTN: LIM LEE AIK PHONE NO : 603 961 1211
LOT PT 7178, BALAKONG N/V, SE DECISION MADE: 03-DEC-99
SERI KEMBANGAN 510(k) STATEMENT
SELANGOR, MALAYSIA 43300
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MI
SRI JOHANI SDN. BHD. 510(k) NO: K993457(TRADITIONAL)
ATTN: LIM LEE AIK PHONE NO : 603 961 1211
LOT PT 7178, BALAKONG N/V, SE DECISION MADE: 02-DEC-99
SERI KEMBANGAN 510(k) STATEMENT
SELANGOR, MALAYSIA 43300
DEVICE: EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
STELLAR BIO SYSTEMS, INC. 510(k) NO: K992587(TRADITIONAL)
ATTN: JOHN BREWER PHONE NO : 410-381-8550
9075 GUILFORD RD. SE DECISION MADE: 22-DEC-99
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPAP/PRO CPAP INTERFACE
STEVENSON INDUSTRIES, INC. 510(k) NO: K992384(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 01-DEC-99
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523
DEVICE: HANG UPS INVERTALIGN
STL INTL., INC. 510(k) NO: K991835(TRADITIONAL)
ATTN: ROGER C TEETER PHONE NO : 253-840-5252
10004 162ND ST. CT. EAST SE DECISION MADE: 20-DEC-99
PUYULLUP, WA 98375 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERFACE MODULE IDDD
STOCKERT INSTRUMENTE 510(k) NO: K992635(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 20-DEC-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
STRYKER CORP. 510(k) NO: K991706(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 800-253-3210
4100 EAST MILHAM AVENUE SE DECISION MADE: 07-DEC-99
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER,
STRYKER INSTRUMENTS 510(k) NO: K994053(SPECIAL)
ATTN: SUSANNE VELAQUEZ PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 20-DEC-99
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
SULZER CARBOMEDICS, INC. 510(k) NO: K993288(TRADITIONAL)
ATTN: EDWARD E NEWTON PHONE NO : 512-435-3407
1300 EAST ANDERSON LN. SE DECISION MADE: 29-DEC-99
AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APR METASUL ACETABULAR INSERT
SULZER MEDICA 510(k) NO: K993569(SPECIAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9900
9900 SPECTRUM DRIVE SE DECISION MADE: 01-DEC-99
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MS-30 FEMORAL STEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K993043(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9900
9900 SPECTRUM DR. SE DECISION MADE: 02-DEC-99
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
SULZERMEDICA 510(k) NO: K990503(TRADITIONAL)
ATTN: EDWARD E NEWTON PHONE NO : 512-435-3407
1300 EAST ANDERSON LANE SE DECISION MADE: 09-DEC-99
AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERM
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K993485(TRADITIONAL)
ATTN: MING SUN PHONE NO : 856-401-1080
604 VPR CENTER SE DECISION MADE: 27-DEC-99
1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BLACKWOOD, NJ 08012
DEVICE: SURE-WAY REUSABLE SHARPS CONTAINER
SURE-WAY SYSTEMS, INC. 510(k) NO: K992626(TRADITIONAL)
ATTN: GARY CHILCOTT PHONE NO : 310-522-0150
310 HARRY BRIDGES BLVD. SE DECISION MADE: 16-DEC-99
WILMINGTON, CA 90744 510(k) STATEMENT
DEVICE: STEALTHSTATION TREATMENT GUIDANCE PLATFORM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K992927(TRADITIONAL)
ATTN: ANGELIQUE DESTRUEL PHONE NO : 303-439-9709
530 COMPTON ST. SE DECISION MADE: 29-DEC-99
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
SURVIVALINK CORP. 510(k) NO: K993072(TRADITIONAL)
ATTN: SEW-WAH TAY PHONE NO : 612-939-2942
5420 FELTL RD. SE DECISION MADE: 10-DEC-99
MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMASEED, MODEL BT-125-1
SYNCOR PHARMACEUTICALS, INC. 510(k) NO: K992008(TRADITIONAL)
ATTN: GARY GILMORE PHONE NO : 303-279-1914
1313 WASHINGTON AVENUE SE DECISION MADE: 23-DEC-99
GOLDEN, CO 80401 510(k) STATEMENT
DEVICE: SYNTHES LIGHT GUIDE
SYNTHES (USA) 510(k) NO: K993314(ABBREVIATED)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1303 GOSHEN PKWY. SE DECISION MADE: 06-DEC-99
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CERVIFIX SYSTEM
SYNTHES (USA) 510(k) NO: K994187(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 21-DEC-99
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVE
SYVA CO. 510(k) NO: K993755(ABBREVIATED)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 21-DEC-99
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: E. HISTOLYTICA II
TECHLAB, INC. 510(k) NO: K994101(SPECIAL)
ATTN: DAVID M LYERLY PHONE NO : 800-832-4522
1861 PRATT DR., STE. 1030 SE DECISION MADE: 21-DEC-99
BLACKSBURG, VA 24060-6364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORC
TELEMED SYSTEMS, INC. 510(k) NO: K992390(TRADITIONAL)
ATTN: JOHN A CHAVES PHONE NO : 508-481-6718
19 BRIGHAM ST., UNIT 1 SE DECISION MADE: 22-DEC-99
MARLBOROUGH, MA 01752 510(k) STATEMENT
DEVICE: 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENC
TELEMED SYSTEMS, INC. 510(k) NO: K992402(TRADITIONAL)
ATTN: JOHN A CHAVES PHONE NO : 508-481-6718
19 BRIGHAM ST., UNIT 1 SE DECISION MADE: 22-DEC-99
MARLBOROUGH, MA 01752 510(k) STATEMENT
DEVICE: DRUG STOP
TEXAS IMMUNOLOGY, INC. 510(k) NO: K991465(TRADITIONAL)
ATTN: CHARLES W GILL PHONE NO : 903-566-6696
12524 FM 3226 SE DECISION MADE: 10-DEC-99
TYLER, TX 75707 510(k) STATEMENT
DEVICE: POWDER FREE LATEX STERILE SURGICAL GLOVES
TG MEDICAL SDN BHD 510(k) NO: K993562(TRADITIONAL)
ATTN: T.S. PUON PHONE NO : 603 392 7880
LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 29-DEC-99
OFF JLN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 41050
DEVICE: C3 MININEPH ANTISERUM
THE BINDING SITE, LTD. 510(k) NO: K981783(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: IGM MININEPH ANTISERUM
THE BINDING SITE, LTD. 510(k) NO: K981784(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 21-DEC-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: C4 MININEPH ANTISERUM
THE BINDING SITE, LTD. 510(k) NO: K981785(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATI
THE BINDING SITE, LTD. 510(k) NO: K981915(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
THE BINDING SITE, LTD. 510(k) NO: K982100(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
THE BINDING SITE, LTD. 510(k) NO: K993612(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 21-DEC-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: BINDAZYME ANTI-DSDNA EIA KIT
THE BINDING SITE, LTD. 510(k) NO: K993727(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 21-DEC-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: MPM REGENECARE WOUND GEL
THE DIVERSIFIED COMPANIES 510(k) NO: K992074(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST DRIVE SE DECISION MADE: 23-DEC-99
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODUS SAGITTAL SPLIT PLATE
THE STRAUMANN CO. 510(k) NO: K993862(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PL. 1601 TRAPELO RD. SE DECISION MADE: 29-DEC-99
WALTHAM, MA 02154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING
THERMOLASE CORP. 510(k) NO: K993209(TRADITIONAL)
ATTN: GERALD FELDMAN, MPH, MBA PHONE NO : 732-329-1787
6 WESTMINSTER PLACE SE DECISION MADE: 23-DEC-99
MONMOUTH JCT., NJ 08852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREEN POWDERED LATEX EXAMINATION GLOVES
TOP GLOVE SDN. BHD. 510(k) NO: K993452(TRADITIONAL)
ATTN: T.S. PUON PHONE NO : 603 392 1992
LOT 4968 JALAN TERATAI, BATU 6 SE DECISION MADE: 20-DEC-99
OFFJALAN MERU, 41050 KLANG 510(k) STATEMENT
SELANGOR, D.E., MALAYSIA
DEVICE: PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
TOP GLOVE SDN. BHD. 510(k) NO: K993605(TRADITIONAL)
ATTN: WEE-CHAI LIM PHONE NO : 603 392 12918410
LOT 4968 JALAN TERATAI, BATU 6 SE DECISION MADE: 20-DEC-99
OFFJALAN MERU, 41050 KLANG 510(k) STATEMENT
SELANGOR, D.E., MALAYSIA
DEVICE: SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
TOP GLOVE SDN. BHD. 510(k) NO: K993680(TRADITIONAL)
ATTN: WEE-CHAI LIM PHONE NO : 603 392 1992
41050 KLANG,SELANGOR SE DECISION MADE: 13-DEC-99
DARUL EHSAN, MALAYSIA 510(k) STATEMENT
DEVICE: AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K992992(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 03-DEC-99
P O BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068
DEVICE: UNI-GOLD H. PYLORI
TRINITY BIOTECH, PLC 510(k) NO: K991697(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768
575 SHIRLYNN COURT SE DECISION MADE: 21-DEC-99
LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARPLAN EASY II HOME PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K993333(TRADITIONAL)
ATTN: LOUISE ROBERTS PHONE NO : 441 234 835564
PRIORY BUSINESS PARK SE DECISION MADE: 16-DEC-99
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: CLEARVIEW EASY HCG PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K993703(TRADITIONAL)
ATTN: LOUISE ROBERTS PHONE NO : 441 234 835564
PRIORY BUSINESS PARK SE DECISION MADE: 02-DEC-99
BEDFORD, UNITED KINGDOM MK 44 3UP 510(k) STATEMENT
DEVICE: QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B,
UNITED PACIFIC CO., LTD. 510(k) NO: K993123(TRADITIONAL)
ATTN: DANIEL YE HUA PHONE NO : 626-458-8518
219 SOUTH RAYMOND AVE. SE DECISION MADE: 17-DEC-99
ALHAMBRA, CA 91801 510(k) STATEMENT
DEVICE: BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K984168(TRADITIONAL)
ATTN: DEAN SECREST PHONE NO : 440-639-4494
5976 HEISELY ROAD SE DECISION MADE: 07-DEC-99
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TONGUE STABILIZER DEVICE
UNIVERSITY OF OTAGO 510(k) NO: K993381(TRADITIONAL)
ATTN: CHRISTINA M LAJOIE PHONE NO : 716-695-6251
199 FIRE TOWER DRIVE SE DECISION MADE: 21-DEC-99
P.O. BOX 5111 510(k) STATEMENT
TONAWANDA, NY 14151-5111
DEVICE: LEMAITRE EMBOLECTOMY CATHETER
VASCUTECH, INC. 510(k) NO: K992368(TRADITIONAL)
ATTN: TRENT G KAMKE PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE SE DECISION MADE: 09-DEC-99
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/961
VIDAR SYSTEMS CORP. 510(k) NO: K993597(TRADITIONAL)
ATTN: MARY "PENNIE" DRINKARD PHONE NO : 703-471-7070
460 SPRING PARK PL. SE DECISION MADE: 15-DEC-99
HERNDON, VA 20170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO L-TYPE GOT TEST
WAKO CHEMICALS, USA, INC. 510(k) NO: K993468(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 16-DEC-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT LATEX EXAMINATION "POWDER-FREE" POLYMER COATED GLOVES
WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K992676(TRADITIONAL)
ATTN: CLAUDE COTTET PHONE NO : 03 376 3525
LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 16-DEC-99
NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000
DEVICE: PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K992681(TRADITIONAL)
ATTN: CLAUDE COTTET PHONE NO : 03 376 3525
LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 16-DEC-99
NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000
DEVICE: HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER
WECK CLOSURE SYSTEMS 510(k) NO: K993157(TRADITIONAL)
ATTN: BRIAN YOUNG PHONE NO : 919-361-4041
ONE WECK DR. SE DECISION MADE: 17-DEC-99
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT
WESLEY JESSEN CORP. 510(k) NO: K993935(TRADITIONAL)
ATTN: JOSEPH F FOOS PHONE NO : 847-294-3306
333 EAST HOWARD AVE. SE DECISION MADE: 21-DEC-99
DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
WINCHESTER LABORATORIES LLC 510(k) NO: K993969(TRADITIONAL)
ATTN: HOWARD ROSE PHONE NO : 630-406-8680
325 NORTH WATER STREET SE DECISION MADE: 30-DEC-99
BATAVIA, IL 60510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUCPREP BREAST ASPIRATOR, MODEL PMPO2
WINDY HILL TECHNOLOGY, INC. 510(k) NO: K993342(TRADITIONAL)
ATTN: ANGELA B SOITO PHONE NO : 650-566-2330
1010 HAMILTON COURT SE DECISION MADE: 23-DEC-99
MENLO COURT, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
WOODSIDE BIOMEDICAL, INC. 510(k) NO: K983907(TRADITIONAL)
ATTN: CAROL L PATTERSON PHONE NO :
18140 SMOKESIGNAL DRIVE SE DECISION MADE: 09-DEC-99
SAN DIEGO, CA 92127 510(k) STATEMENT
DEVICE: SADDLE SHAPED PATELLA
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K993371(TRADITIONAL)
ATTN: LYNNE WITKOWSKI PHONE NO : 901-867-4620
5677 AIRLINE RD. SE DECISION MADE: 20-DEC-99
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CON
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K993214(TRADITIONAL)
ATTN: OOI SOO KANG PHONE NO : 603 846 2055
LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 02-DEC-99
BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900
DEVICE: DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K993215(TRADITIONAL)
ATTN: OOI SOO KANG PHONE NO : 603 846 2055
LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 02-DEC-99
BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900
DEVICE: PENSIL TRAUMA, MODEL WWS6100
WUESTEC MEDICAL, INC. 510(k) NO: K993962(TRADITIONAL)
ATTN: BRENDA S. D. DAVIS PHONE NO : 334-408-0200
5600 COMMERCE BLVD., EAST SE DECISION MADE: 21-DEC-99
MOBILE, AL 36619-0037 510(k) STATEMENT
DEVICE: XOMED ENT RF SYSTEM
XOMED, INC. 510(k) NO: K993112(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 09-DEC-99
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
XOMED, INC. 510(k) NO: K993655(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 21-DEC-99
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
Y-CLIP ASSOCIATES 510(k) NO: K993424(TRADITIONAL)
ATTN: GEORGE YU PHONE NO :
116 DEFENSE HIGHWAY SE DECISION MADE: 23-DEC-99
ANNAPOLIS, MD 21401 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 319
TOTAL WITH SUMMARIES 219
TOTAL WITH STATEMENTS 100
Updated 4/12/2000
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