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510(k)s Final Decisions Rendered for December 1999 |
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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