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Medical Devices
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January 2000 510(k) Clearances
DEVICE: EMS KERMIT (EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K992504(TRADITIONAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 27-JAN-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M TR SYSTEM 3M CO. 510(k) NO: K992489(TRADITIONAL) ATTN: LAEL J PICKETT PHONE NO : 651-733-3594 3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 11-JAN-00 ST. PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNEA - LS LOW-SPEED HANDPIECE A-DEC, INC. 510(k) NO: K993526(TRADITIONAL) ATTN: PATRICK RIDENOUR PHONE NO : 503-537-2756 2601 CRESTVIEW DR. SE DECISION MADE: 11-JAN-00 NEWBERG, OR 97132-9257 510(k) STATEMENT DEVICE: EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000 ACCULASE, INC. 510(k) NO: K992914(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 760-602-3300 2431 IMPALA DRIVE SE DECISION MADE: 27-JAN-00 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACON ONE STEP HOME PREGNANCY TEST STRIP ACON LABORATORIES, INC. 510(k) NO: K993483(TRADITIONAL) ATTN: NORA C.R. YORK PHONE NO : 858-535-2030 11175 FLINTKOTE AVE., #F & G SE DECISION MADE: 20-JAN-00 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMED SUTURE ANCHOR ACUMED, INC. 510(k) NO: K993657(TRADITIONAL) ATTN: SHARI JEFFERS PHONE NO : 503-627-9957 10950 S.W. 5TH ST., SUITE 170 SE DECISION MADE: 13-JAN-00 BEAVERTON, OR 97005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991391(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVENUE SAUSALITO SE DECISION MADE: 10-JAN-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: AESCULAP VASCULAR INSTRUMENTS AESCULAP, INC. 510(k) NO: K992053(TRADITIONAL) ATTN: MARY ELLEN HOLDEN PHONE NO : 650-642-5072 1000 GATEWAY BLVD. SE DECISION MADE: 13-JAN-00 SOUTH SAN FRANCISCO, CA 94080-7030510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOCON SPINAL SYSTEM AESCULAP, INC. 510(k) NO: K993551(TRADITIONAL) ATTN: LIA S JONES PHONE NO : 650-876-7000 1000 GATEWAY BLVD. SE DECISION MADE: 13-JAN-00 SOUTH SAN FRANCISCO, CA 94080-7030510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENAFLOW SYSTEM, MODEL 30A AIRCAST, INC. 510(k) NO: K992454(TRADITIONAL) ATTN: STEPHEN KENNEY PHONE NO : 908-273-6349 92 RIVER RD. SE DECISION MADE: 13-JAN-00 SUMMIT, NJ 07902 510(k) STATEMENT DEVICE: AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K993522(TRADITIONAL) ATTN: JOAN ZACHAROPOULOS PHONE NO : 914-268-0101 360 NORTH ROUTE 9W SE DECISION MADE: 10-JAN-00 CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD. 510(k) NO: K992767(ABBREVIATED) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 10-JAN-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERTORS SURGICAL DRAPES ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K993795(TRADITIONAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 12-JAN-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY ALPHA OMEGA LTD. 510(k) NO: K993622(TRADITIONAL) ATTN: SHOSHANA S FRIEDMN PHONE NO : 972 771 8130 117 AHUZAH ST. SE DECISION MADE: 24-JAN-00 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD ALPHATEC MFG., INC. 510(k) NO: K993873(TRADITIONAL) ATTN: JASON BLAIN PHONE NO : 760-779-8250 42-160 STATE ST. SE DECISION MADE: 03-JAN-00 PALM DESERT, CA 92211-5148 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAMLOG CYLINDER IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES 510(k) NO: K000065(SPECIAL) ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707 9229 CRANFORD DRIVE SE DECISION MADE: 28-JAN-00 POTOMAC, MD 20854 510(k) STATEMENT DEVICE: CAMLOG SCREW IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES 510(k) NO: K000099(SPECIAL) ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707 9229 CRANFORD DRIVE SE DECISION MADE: 28-JAN-00 POTOMAC, MD 20854 510(k) STATEMENT DEVICE: CAMLOG ROOTFORM IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES 510(k) NO: K000100(SPECIAL) ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707 9229 CRANFORD DRIVE SE DECISION MADE: 28-JAN-00 POTOMAC, MD 20854 510(k) STATEMENT DEVICE: A-22 HEMODIALYZER ALTHIN MEDICAL AB 510(k) NO: K992563(TRADITIONAL) ATTN: LARS-OLOF SANDBERB PHONE NO : 464-577-5900 FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00 RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AF-180 HEMODIALYZER ALTHIN MEDICAL AB 510(k) NO: K992564(TRADITIONAL) ATTN: LARS-OLOF SANDBERG PHONE NO : 464-577-5900 FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00 RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AF-150 HEMODIALYZER ALTHIN MEDICAL AB 510(k) NO: K992566(TRADITIONAL) ATTN: LARS-OLOF SANDBERG PHONE NO : 464-577-5900 FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00 RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AF-220 HEMODIALYZER ALTHIN MEDICAL AB 510(k) NO: K992573(TRADITIONAL) ATTN: LARS-OLOF SANDBERB PHONE NO : 464-577-5900 FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00 RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADID DRUG SCREEN 5-PANEL TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K993151(TRADITIONAL) ATTN: JOHN B DUBECK PHONE NO : 202-434-4125 1001 G STREET, NW SE DECISION MADE: 10-JAN-00 SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20001 DEVICE: RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CAN AMERICAN BIO MEDICA CORP. 510(k) NO: K993961(TRADITIONAL) ATTN: HENRY WELLS PHONE NO : 800-227-1243 122 SMITH ROAD SE DECISION MADE: 24-JAN-00 KINDERHOOK, NY 12106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABI VEST AIRWAY CLEARANCE SYSTEM AMERICAN BIOSYSTEMS, INC. 510(k) NO: K993629(TRADITIONAL) ATTN: ERIC J LARSON PHONE NO : 651-234-1211 20 YORKTON CT. SE DECISION MADE: 21-JAN-00 ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIVA SYSTEM, MODEL SL1010 AMERICAN TELECARE, INC. 510(k) NO: K993550(TRADITIONAL) ATTN: CHARLES RICHARD ABRUSCATO PHONE NO : 612-897-0000 7640 GOLDEN TRIANGLE DR. SE DECISION MADE: 13-JAN-00 EDEN PRAIRIE, MN 55344-3732 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE AMSINO INTL., INC. 510(k) NO: K992719(TRADITIONAL) ATTN: RICHARD Y LI PHONE NO : 909-626-3783 833 TOWNE CENTER DR. SE DECISION MADE: 12-JAN-00 POMONA, CA 91767 510(k) STATEMENT DEVICE: AMUKIN D AMUCHINA INTL., INC. 510(k) NO: K992016(TRADITIONAL) ATTN: LUDOVICO GIAVOTTO PHONE NO : 301-330-7597 8-8 METROPLITAN CT. SE DECISION MADE: 10-JAN-00 GAITHERSBURG, MD 20878 510(k) STATEMENT DEVICE: AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM AMYLIOR INC. 510(k) NO: K994072(TRADITIONAL) ATTN: SYLVAIN DUGAS PHONE NO : 514 453 0311 6 ANTOINE-HENAULT SE DECISION MADE: 13-JAN-00 NOTE-DAME OF ILE PERROT,QUEBEC, CA510(k) STATEMENT DEVICE: AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FR AMYLIOR INC. 510(k) NO: K994107(TRADITIONAL) ATTN: SYLVAIN DUGAS PHONE NO : 514 453 0311 6 ANTOINE-HENAULT SE DECISION MADE: 13-JAN-00 NOTE-DAME OF ILE PERROT,QUEBEC, CA510(k) STATEMENT DEVICE: THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVE ANSELL PERRY INC. 510(k) NO: K993857(TRADITIONAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 31-JAN-00 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU ARTHREX, INC. 510(k) NO: K990340(TRADITIONAL) ATTN: VERNON C BROWN PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 28-JAN-00 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B ARTHREX, INC. 510(k) NO: K990987(TRADITIONAL) ATTN: VERNON BROWN PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 13-JAN-00 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K994330(SPECIAL) ATTN: CHRISTINE MORGIDA PHONE NO : 508-653-0603 2 VISION DR. SE DECISION MADE: 18-JAN-00 NATICK, MA 01760-2059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT ATRIUM MEDICAL CORP. 510(k) NO: K992991(TRADITIONAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 27-JAN-00 HUDSON, NH 03051 510(k) STATEMENT DEVICE: AUTOMATED OPHTHALMICS SOFTIPS AUTOMATED OPHTHALMICS, INC. 510(k) NO: K992998(TRADITIONAL) ATTN: NORMAN BICKMAN PHONE NO : 800-242-5602 8253 GLEMAR ROAD SE DECISION MADE: 10-JAN-00 ELLICOTT, MD 21043 510(k) STATEMENT DEVICE: MODIFICATION TO BONE ANCHOR AND KIT (BAK) AXYA MEDICAL, INC. 510(k) NO: K994313(SPECIAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 100 CUMMINGS CENTER SE DECISION MADE: 13-JAN-00 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: CELSITE, MODELS ST401L, ST405L B. BRAUN/MCGAW 510(k) NO: K994111(SPECIAL) ATTN: VALERIE LEWIS PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 03-JAN-00 ALLENTOWN, PA 18103-9341 510(k) STATEMENT DEVICE: VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) BAUSCH & LOMB, INC. 510(k) NO: K993039(TRADITIONAL) ATTN: VANADA JOHNSON PHONE NO : 636-226-3182 3365 TREE COURT INDUSTRIAL BLV SE DECISION MADE: 07-JAN-00 ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS HYBRITECH FREE PSA QC, MODEL 37219 BECKMAN COULTER, INC. 510(k) NO: K993210(TRADITIONAL) ATTN: MICHEL GUST PHONE NO : 612-368-7688 1000 LAKE HAZELTINE DR. SE DECISION MADE: 05-JAN-00 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS BECKMAN COULTER, INC. 510(k) NO: K993954(TRADITIONAL) ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777 200 SOUTH KRAEMER BLVD.,W-337 SE DECISION MADE: 11-JAN-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS HYBRITECH PSA QC, MODEL 37209 BECKMAN COULTER, INC. 510(k) NO: K994200(TRADITIONAL) ATTN: MICHELE GUST PHONE NO : 612-368-7688 1000 LAKE HAZELTINE DR. SE DECISION MADE: 18-JAN-00 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS OSTASE QC BECKMAN COULTER, INC. 510(k) NO: K994277(TRADITIONAL) ATTN: MARA CALER PHONE NO : 858-621-4583 7330 CARROLL ROAD SE DECISION MADE: 14-JAN-00 SAD DIEGO, CA 92196-9006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR BECKMAN COULTER, INC. 510(k) NO: K994325(TRADITIONAL) ATTN: GAIL LEFEBVRE PHONE NO : 714-993-8503 200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 12-JAN-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 3 BECKMAN COULTER, INC. 510(k) NO: K994439(TRADITIONAL) ATTN: MICHELE S GUST PHONE NO : 612-368-7688 1000 LAKE HAZELTINE DR. SE DECISION MADE: 14-JAN-00 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP BELMONT INSTRUMENT CORP. 510(k) NO: K983866(TRADITIONAL) ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212 780 BOSTON RD. SE DECISION MADE: 06-JAN-00 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICR BESGLOVE MEDICARE SDN. BHD. 510(k) NO: K994082(TRADITIONAL) ATTN: LEE AIK LIM PHONE NO : 603 825 6361 LOT 6, JALAN P/2A SE DECISION MADE: 28-JAN-00 BANGI INDUSTRIAL ESTATE 510(k) STATEMENT KAJANG,SELANGOR DARUL,EHASAN, MALAYSIA 43000 DEVICE: THE 4.5MM DIAMETER BICON DENTAL IMPLANT BICON, INC. 510(k) NO: K994037(TRADITIONAL) ATTN: VINCENT J MORGAN PHONE NO : 617-524-4443 1153 CENTRE STREET SE DECISION MADE: 11-JAN-00 BOSTON, MA 02130 510(k) STATEMENT DEVICE: FORTOSS-CEMA BIOCOMPOSITES LTD. 510(k) NO: K993238(TRADITIONAL) ATTN: JS BRATT PHONE NO : 44 178 2206500 ETRUSCAN ST., ETRURIA SE DECISION MADE: 14-JAN-00 STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE AUTOTAC SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K993493(TRADITIONAL) ATTN: WINSTON D GREER PHONE NO : 205-967-7880 ONE PERIMETER PARK SOUTH SE DECISION MADE: 07-JAN-00 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: MSA-21 BIOMERIDIAN, INC. 510(k) NO: K993824(SPECIAL) ATTN: JOE GALLOWAY PHONE NO : 801-501-7517 12411 SOUTH 265 WEST SE DECISION MADE: 20-JAN-00 SUITE F 510(k) SUMMARY AVAILABLE FROM FDA DRAPER, UT 84020 DEVICE: ASCENT KNEE SYSTEM BIOMET MANUFACTURING, INC. 510(k) NO: K994326(SPECIAL) ATTN: TRACY J BICKEL PHONE NO : 219-372-1761 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 07-JAN-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES BIOPRO (M) SDN BHD 510(k) NO: K994043(TRADITIONAL) ATTN: JAMES H LALE PHONE NO : 603 376 1390 LOT14, PT.4204 LINGKARN SULTAN SE DECISION MADE: 11-JAN-00 HISHAMUDDIN, NORTH PORT INDU. 510(k) STATEMENT PORT KLANG, MALAYSIA 42000 DEVICE: SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE- BIOSURGICAL CORP. 510(k) NO: K000048(SPECIAL) ATTN: TERRY LAAS PHONE NO : 925-737-1850 5990 STONERIDGE DRIVE SE DECISION MADE: 31-JAN-00 SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94555 DEVICE: HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 BIRD PRODUCTS CORP. 510(k) NO: K990856(TRADITIONAL) ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255 1100 BIRD CENTER DR. SE DECISION MADE: 11-JAN-00 PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE BOSTON SCIENTIFIC CORP. 510(k) NO: K994252(SPECIAL) ATTN: ANDREA BOUMIS PHONE NO : 408-895-3625 2710 ORCHARD PKWY. SE DECISION MADE: 04-JAN-00 SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIA BOSTON SCIENTIFIC, TARGET 510(k) NO: K993415(TRADITIONAL) ATTN: ROXANE BAXTER PHONE NO : 510-624-2105 47900 BAYSIDE PARKWAY SE DECISION MADE: 21-JAN-00 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GU BOSTON SCIENTIFIC, TARGET 510(k) NO: K993417(TRADITIONAL) ATTN: ROXANE BAXTER PHONE NO : 510-624-2105 47900 BAYSIDE PARKWAY SE DECISION MADE: 21-JAN-00 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL BOSTON SCIENTIFIC, TARGET 510(k) NO: K993418(TRADITIONAL) ATTN: ROXANE BAXTER PHONE NO : 510-624-2105 47900 BAYSIDE PARKWAY SE DECISION MADE: 21-JAN-00 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAINLAB STEREOTACTIC ARC BRAINLAB 510(k) NO: K992916(TRADITIONAL) ATTN: ERIC LINDQUIST PHONE NO : 650-494-7240 100 MARINE PARKWAY SE DECISION MADE: 11-JAN-00 SUITE 305 510(k) STATEMENT REDWOOD CITY, CA 94065 DEVICE: COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MOD BRONCUS TECHNOLOGIES, INC. 510(k) NO: K993900(TRADITIONAL) ATTN: JOHN D'ANGELO PHONE NO : 650-428-1600 1400N SHORELINE BLVD. SE DECISION MADE: 28-JAN-00 BLDG. A, SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94043 DEVICE: MULTIFUNCTION KEITO K5 BUMEDCO INTL., INC. 510(k) NO: K984083(TRADITIONAL) ATTN: DARROLD GLANVILLE PHONE NO : 651-787-0625 725 TIMBER LANE SE DECISION MADE: 18-JAN-00 SHOREVIEW, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD MEMOTHERM FLEXX BILIARY STENT C.R. BARD, INC. 510(k) NO: K993392(ABBREVIATED) ATTN: CAROL VIERLING PHONE NO : 770-385-2347 13183 HARLAND DR. SE DECISION MADE: 06-JAN-00 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD UROFORCE BALLOON DILATION CATHETER C.R. BARD, INC. 510(k) NO: K993840(ABBREVIATED) ATTN: ANGELA L BUNN PHONE NO : 770-784-6774 8195 INDUSTRIAL BLVD. SE DECISION MADE: 31-JAN-00 COVINGTON, GA 30209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DUR C.R. BARD, INC. 510(k) NO: K993892(SPECIAL) ATTN: MARION GORDON PHONE NO : 978-262-4867 129 CONCORD RD., BLDG. 3 SE DECISION MADE: 06-JAN-00 BILLERICA, MA 01821-7031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA SCLERO LONG PULSE DYE LASER CANDELA CORP. 510(k) NO: K993671(TRADITIONAL) ATTN: JOAN CLIFFORD PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 24-JAN-00 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRITERION 40 OR PM 40 CARADYNE, LTD. 510(k) NO: K992101(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 06-JAN-00 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERHEART AECD CARDIAC SCIENCE, INC. 510(k) NO: K993533(SPECIAL) ATTN: STAN E TILLMAN PHONE NO : 949-587-0357 16931 MILLIKAN AVE. SE DECISION MADE: 24-JAN-00 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K993519(TRADITIONAL) ATTN: PETER SCOTT PHONE NO : 919-874-6103 5301 DEPARTURE DR. SE DECISION MADE: 14-JAN-00 RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAIN CASE MEDICAL, INC. 510(k) NO: K991023(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7561 1900 K STREET, N.W. SE DECISION MADE: 27-JAN-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLO-CARE BRAND HARD SOLUTION CIBA VISION CORP. 510(k) NO: K993949(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 770-418-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 05-JAN-00 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARPVIEW IMAGE ENHANCEMENT SYSTEM CONTEXTVISION AB 510(k) NO: K993802(TRADITIONAL) ATTN: CONSTANCE BUNDY PHONE NO : 612-574-1976 6470 RIVERVIEW TERRACE SE DECISION MADE: 18-JAN-00 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIS WOUND DRESSING II COOK BIOTECH, INC. 510(k) NO: K993948(TRADITIONAL) ATTN: NEAL E FEARNOT PHONE NO : 765-497-3355 3055 KENT AVE. SE DECISION MADE: 06-JAN-00 WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIPPER DETACHABLE EMBOLIZATION COIL COOK, INC. 510(k) NO: K993455(TRADITIONAL) ATTN: KAREN BRADBURN PHONE NO : 800-346-2686 925 S. CURRY PIKE SE DECISION MADE: 11-JAN-00 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER CORDIS CORP. 510(k) NO: K993720(TRADITIONAL) ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332 14201 N.W. 60TH AVE. SE DECISION MADE: 18-JAN-00 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY CORDIS CORP. 510(k) NO: K994156(SPECIAL) ATTN: CHARLES J RYAN PHONE NO : 908-412-7446 7 POWDERHORN DRIVE SE DECISION MADE: 07-JAN-00 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATW MARKER WIRE STEERABLE GUIDEWIRE CORDIS CORP. 510(k) NO: K994358(SPECIAL) ATTN: DENNIS S GRIFFIN PHONE NO : 305-824-5283 14201 N.W. 60TH AVE. SE DECISION MADE: 13-JAN-00 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENAMEL SCULPT COSMEDENT, INC. 510(k) NO: K993658(TRADITIONAL) ATTN: MICHAEL O'MALLEY PHONE NO : 773-989-6844 5419 NORTH SHERIDAN RD. SE DECISION MADE: 18-JAN-00 CHICAGO, IL 60640 510(k) STATEMENT DEVICE: RENAMEL PACK COSMEDENT, INC. 510(k) NO: K993659(TRADITIONAL) ATTN: MICHAEL O'MALLEY PHONE NO : 773-989-6844 5419 NORTH SHERIDAN RD. SE DECISION MADE: 18-JAN-00 CHICAGO, IL 60640 510(k) STATEMENT DEVICE: INTRAVASCULAR ADMINISTRATION SET CUSTOM ASSEMBLIES, INC. 510(k) NO: K993463(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 04-JAN-00 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL CYNOSURE, INC. 510(k) NO: K994427(SPECIAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 18-JAN-00 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE PHOTOGENICA SPIR CYNOSURE, INC. 510(k) NO: K994437(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 18-JAN-00 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCED D-DIMER DADE BEHRING, INC. 510(k) NO: K992957(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 28-JAN-00 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714 DEVICE: BEHRING COAGULATION SYSTEM (BCS) DADE BEHRING, INC. 510(k) NO: K992959(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 11-JAN-00 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714 DEVICE: DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR DADE BEHRING, INC. 510(k) NO: K994114(TRADITIONAL) ATTN: ROBIN O NORRIS PHONE NO : 302-631-7446 P.O. BOX 6101 SE DECISION MADE: 20-JAN-00 GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K994115(TRADITIONAL) ATTN: ROBIN O NORRIS PHONE NO : 302-631-7446 BLDG. 500 MAIL BOX 514 SE DECISION MADE: 28-JAN-00 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: MICROSTREP PLUS PANEL, VANCOMYCIN DADE MICROSCAN, INC. 510(k) NO: K983953(TRADITIONAL) ATTN: SHAROLYN J LENTSCH PHONE NO : 916-374-8183 1584 ENTERPRISE BLVD. SE DECISION MADE: 14-JAN-00 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN DADE MICROSCAN, INC. 510(k) NO: K993679(TRADITIONAL) ATTN: TREVOR WALL PHONE NO : 916-374-3222 2040 ENTERPRISE BLVD. SE DECISION MADE: 14-JAN-00 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX DATASCOPE CORP. 510(k) NO: K993531(ABBREVIATED) ATTN: SUSAN E MANDY PHONE NO : 201-967-2229 580 WINTERS AVENUE SE DECISION MADE: 13-JAN-00 PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERGOGOLD DEGUSSA - NEY DENTAL, INC. 510(k) NO: K993897(TRADITIONAL) ATTN: ANDREW J PIETROBONO PHONE NO : 954-429-2886 1065 S.W. 30TH AVE. SE DECISION MADE: 10-JAN-00 DEERFIELD BEACH, FL 33442-8193 510(k) STATEMENT DEVICE: DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE DEPUY, INC. 510(k) NO: K993465(TRADITIONAL) ATTN: ARLENE C SAULL PHONE NO : 219-371-4904 700 ORTHOPAEDIC DR. SE DECISION MADE: 11-JAN-00 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K993920(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 18-JAN-00 WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT CHARLOTTETOWN, P.E.I., CANADA C1E 2A6 DEVICE: IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K992632(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 27-JAN-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K992634(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 20-JAN-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K994085(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 28-JAN-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOS-A-SCOPE DISPOS-A-SCOPE 510(k) NO: K993738(TRADITIONAL) ATTN: LAUREL NICHOLAS PHONE NO : 208-743-4567 315 SKYLINE DRIVE SE DECISION MADE: 06-JAN-00 LEWISTON, ID 83501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNATRON 900 DYNATRONICS CORP. 510(k) NO: K993919(TRADITIONAL) ATTN: JOHN S RAMSEY PHONE NO : 801-568-7000 7030 PARK CENTRE DR. SE DECISION MADE: 03-JAN-00 SALT LAKE CITY, UT 84121 510(k) STATEMENT DEVICE: REVELATION POROUS HIP STEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K994070(SPECIAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 20-JAN-00 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSTYLET MODELS EC0010, EC0020 ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K993376(TRADITIONAL) ATTN: JAMES BULLOCK PHONE NO : 651-523-6928 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 05-JAN-00 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EC-7701 FLUID WARMING CABINET ENTHERMICS MEDICAL SYSTEMS, INC. 510(k) NO: K993797(TRADITIONAL) ATTN: EMALEE G MURPHY PHONE NO : 202-496-7255 1900 K STREET NW SE DECISION MADE: 20-JAN-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K992811(ABBREVIATED) ATTN: KRISTA OAKES PHONE NO : 972-801-9854 1800 10TH ST., SUITE 300 SE DECISION MADE: 18-JAN-00 PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM ESC MEDICAL SYSTEMS LTD. 510(k) NO: K991935(TRADITIONAL) ATTN: ZVI LADIN PHONE NO : 781-444-8446 250 FIRST AVENUE SE DECISION MADE: 27-JAN-00 NEEDHAM, MA 02194 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPREGUM GARANT L DUOSOFT ESPE DENTAL AG 510(k) NO: K994190(TRADITIONAL) ATTN: ANDRERAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 27-JAN-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPREGUM PENTA M MONOSOFT ESPE DENTAL AG 510(k) NO: K994192(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 28-JAN-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPREGUM PENTA DUOSOFT ESPE DENTAL AG 510(k) NO: K994193(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 28-JAN-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KETAC-MOLAR QUICK ESPE DENTAL AG 510(k) NO: K994251(SPECIAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 03-JAN-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) ETHICON, INC. 510(k) NO: K994418(SPECIAL) ATTN: GREGORY JONES PHONE NO : 908-218-2481 P.O. BOX 151, ROUTE 22 SE DECISION MADE: 24-JAN-00 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM CO EXACTECH, INC. 510(k) NO: K993736(TRADITIONAL) ATTN: GARY J MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 20-JAN-00 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNA ABUTMENT FACTOR, II, INC. 510(k) NO: K984297(TRADITIONAL) ATTN: JOHN D MCFALL PHONE NO : 520-537-8387 1972 FOREST AVE. SE DECISION MADE: 28-JAN-00 LAKESIDE, AZ 85929 510(k) STATEMENT DEVICE: FAS ENDOLUMINAL BRUSH FAS MEDICAL LTD. 510(k) NO: K993614(TRADITIONAL) ATTN: LYNNE ARONSON PHONE NO : 303-697-8198 PO BOX 219 SE DECISION MADE: 18-JAN-00 INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTE FLEXITECH SDN. BHD. 510(k) NO: K994354(TRADITIONAL) ATTN: Y. F HEW PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 31-JAN-00 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: INSTACHECK MULTI-DRUG THC/COC TEST, MODEL 200C; INSTACHECK MULTI FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K993863(TRADITIONAL) ATTN: FENG-YU LEE PHONE NO : 949-595-0673 23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 27-JAN-00 LAGUNA HILLS, CA 92653 510(k) STATEMENT DEVICE: FRIALIT-2 BONE PROFILER FRIADENT GMBH 510(k) NO: K993560(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 10-JAN-00 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO DQM 200 GAMBRO HEALTHCARE 510(k) NO: K990039(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018 1185 OAK ST. SE DECISION MADE: 27-JAN-00 LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMAGEM SCINTILLATION CAMERA GAMMA MEDICA 510(k) NO: K993813(TRADITIONAL) ATTN: BRADLEY E PATT PHONE NO : 818-709-2468 19355 BUSINESS CENTER DR., SE DECISION MADE: 18-JAN-00 SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA NORTHRIDGE, CA 91324 DEVICE: FUJI II LC CAPSULE GC AMERICA, INC. 510(k) NO: K993973(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH ST. SE DECISION MADE: 11-JAN-00 CHICAGO, IL 60658 510(k) STATEMENT DEVICE: AROMA FINE (NORMAL AND FAST SET) GC AMERICA, INC. 510(k) NO: K994077(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH ST. SE DECISION MADE: 27-JAN-00 CHICAGO, IL 60658 510(k) STATEMENT DEVICE: HEMOSITE TEST SYSTEM GDS TECHNOLOGY, INC. 510(k) NO: K994073(TRADITIONAL) ATTN: KEITH CRAWFORD PHONE NO : 219-264-7384 25235 LEER DRIVE SE DECISION MADE: 14-JAN-00 P.O. BOX 473 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46515 DEVICE: CLINICAL BLOOD GAS MIXTURE GENERAL AIR SERVICE AND SUPPLY 510(k) NO: K993789(TRADITIONAL) ATTN: MICHAEL FISHER PHONE NO : 303-892-7003 6330 COLORADO BLVD. SE DECISION MADE: 10-JAN-00 COMMERCE CITY, CO 80022 510(k) STATEMENT DEVICE: ELECTROSURGICAL ELECTRODE FAMILY GENESIS MEDICAL, INC. 510(k) NO: K992045(TRADITIONAL) ATTN: THOMAS WEHMAN PHONE NO : 408-522-8690 524 WEDDEL DRIVE, SUITE 4 SE DECISION MADE: 27-JAN-00 SUNNYVALE, CA 94089 510(k) STATEMENT DEVICE: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING GLOVCO (M) SDN. BHD. 510(k) NO: K994013(TRADITIONAL) ATTN: TAN CHWEE HOCK PHONE NO : 603 391 3888 LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 20-JAN-00 OFF JALAN MERU 510(k) STATEMENT KLANG, SELANGOR D.E., MALAYSIA 42100 DEVICE: BLUE NITRILE EXAMINATION GLOVES - POWDER FREE GLOVE SOURCE, INC. 510(k) NO: K994064(TRADITIONAL) ATTN: EMMY TJOENG PHONE NO : 626-913-1798 889 SOUTH AZUSA AVE. SE DECISION MADE: 28-JAN-00 CITY OF INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE LIGHT CURING UNIT GREGORY S. JACOB, D.D.S. 510(k) NO: K994048(TRADITIONAL) ATTN: GREGORY S JACOB PHONE NO : 847-298-8954 9672 READING CIRCLE SE DECISION MADE: 13-JAN-00 DES PLAINS, IL 60016 510(k) STATEMENT DEVICE: EIS DYNAMIC MEMORY STAPLES SYSTEM GROUPE LEPINE 510(k) NO: K991962(TRADITIONAL) ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882 962 SOUTH TAMIAMI TRAIL SE DECISION MADE: 10-JAN-00 SUITE 203 510(k) STATEMENT SARASOTA, FL 34326 DEVICE: RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PER GUIDANT CORP. 510(k) NO: K993639(TRADITIONAL) ATTN: SUSAN SILAVIN PHONE NO : 408-235-3127 3200 LAKESIDE DR. SE DECISION MADE: 27-JAN-00 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054-2807 DEVICE: GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K993793(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 12-JAN-00 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: GYNECARE VERSAPOINT G-VAP ELECTRODE GYNECARE, INC. 510(k) NO: K992901(TRADITIONAL) ATTN: GREGORY JONES PHONE NO : 908-218-2481 P.O. BOX 151 SE DECISION MADE: 18-JAN-00 SOMMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARDYDISK DOXYCYCLINE, 30MCG HARDY DIAGNOSTICS 510(k) NO: K994051(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 10-JAN-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK AZTREONAM, 30MCG HARDY DIAGNOSTICS 510(k) NO: K994063(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 14-JAN-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDY DISK AMPICILLIN/SULBACTAM HARDY DIAGNOSTICS 510(k) NO: K994067(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 14-JAN-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK IMIPENEM, 10MCG HARDY DIAGNOSTICS 510(k) NO: K994132(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 18-JAN-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HP M2376A DEVICE LINK SYSTEM HEWLETT-PACKARD CO. 510(k) NO: K993587(TRADITIONAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 20-JAN-00 ANDOVER, MA 01810-1085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MON HEWLETT-PACKARD GMBH 510(k) NO: K992273(ABBREVIATED) ATTN: EGON PFEIL PHONE NO : 703-114-2243 HERRENBERGER STR. 110-140 SE DECISION MADE: 28-JAN-00 BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CITATION TMZF HA STEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K993768(TRADITIONAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283 359 VETERANS BLVD. SE DECISION MADE: 21-JAN-00 RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABY DOPPLEX 4000, MODEL BD 4000 HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K990569(TRADITIONAL) ATTN: AUDREY A WITCO PHONE NO : 227 RT. 33 EAST SE DECISION MADE: 24-JAN-00 MANALAPAN, NJ 07726-8362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUBING EXTENSION SET HURRICANE MEDICAL 510(k) NO: K993361(TRADITIONAL) ATTN: DAVID A CLAPP PHONE NO : 941-751-0588 2331K 63RD AVE. EAST SE DECISION MADE: 04-JAN-00 BRADENTON, FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST INTERSEGMENTAL ROLLER TRACTION TABLE ICON INTL., LLC. 510(k) NO: K993461(TRADITIONAL) ATTN: GERALD S AUSLANDER PHONE NO : 636-527-2707 300 OZARK TRAIL DRIVE #207C SE DECISION MADE: 03-JAN-00 ELLISVILLE, MO 63011 510(k) STATEMENT DEVICE: HANNAH WIRELESS VITAL SIGNS MONITOR ILIFE SYSTEMS, INC. 510(k) NO: K991087(TRADITIONAL) ATTN: JOSHUA A ADLER PHONE NO : 214-365-7400 5910 NORTH CENTRAL EXPRESSWAY SE DECISION MADE: 12-JAN-00 SUITE 1775 510(k) SUMMARY AVAILABLE FROM FDA DALLAS, TX 75206 DEVICE: MRI EQUIPMENT COVER IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K993682(TRADITIONAL) ATTN: DAVID M LEE PHONE NO : 407-757-8990 2290 W. EAU GALLIE BLVD SE DECISION MADE: 20-JAN-00 SUITE 210 510(k) STATEMENT MELBOURNE, FL 32935 DEVICE: WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK INDUSTRIELLE ENTWICKLUNG MEDIZINTE510(k) NO: K991545(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 941-948-2001 11641 RED HIBISCUS DRIVE SE DECISION MADE: 19-JAN-00 BONITA SPRINGS, FL 34135 510(k) STATEMENT DEVICE: HOT SHOT FLUID WARMER IV FLUIDS INFRA-MED TECHNOLOGIES, INC. 510(k) NO: K992258(TRADITIONAL) ATTN: BERTRAM J HUDSON PHONE NO : 972-355-9700 3535 FIREWHEEL DRIVE, SUITE A SE DECISION MADE: 12-JAN-00 FLOWER MOUND, TX 75028-2628 510(k) STATEMENT DEVICE: TITAN RC TACK INNOVASIVE DEVICES, INC. 510(k) NO: K994269(SPECIAL) ATTN: KATHLEEN MORAHAN PHONE NO : 508-460-8229 734 FOREST ST. SE DECISION MADE: 10-JAN-00 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTE INNOVATIVE GLOVES CO; LTD 510(k) NO: K993567(TRADITIONAL) ATTN: RAJEEV KUMAR SOOD PHONE NO : 667 442 8408 11 CHOTEVITTAYAKUL 3 ROAD SE DECISION MADE: 12-JAN-00 KHOHONG, HATYAI,SONGKHLA, THAILAND510(k) STATEMENT DEVICE: QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT INOVA DIAGNOSTICS, INC. 510(k) NO: K994004(TRADITIONAL) ATTN: GARY L NORMAN PHONE NO : 619-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 27-JAN-00 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K991355(TRADITIONAL) ATTN: TRICIA WOOD PHONE NO : 412-854-1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 27-JAN-00 BETHEL PARK, PA 15102 510(k) STATEMENT DEVICE: INTER-OS BONE GENERATOR INTER-OS TECHNOLOGIES, L.L.C. 510(k) NO: K993869(TRADITIONAL) ATTN: RANDOLPH C ROBINSON PHONE NO : 303-699-7970 7144 S. CHAPPARAL CIR. E. SE DECISION MADE: 19-JAN-00 AURORA, CO 80016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 INTERCONTINENTAL NEW TECHNOLOGIES,510(k) NO: K992256(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 11-JAN-00 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBC FLOGUARD, MODEL 6050 INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K992785(TRADITIONAL) ATTN: H. DAVID SHOCKLEY, JR PHONE NO : 512-326-3244 4020 SOUTH INDUSTRIAL DR. SE DECISION MADE: 14-JAN-00 SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78744 DEVICE: URINALYSIS REAGENT STRIPS (10 PARAMETERS) INTERNATIONAL NEWTECH DEVELOPMENT,510(k) NO: K993850(TRADITIONAL) ATTN: DENNIS S.L. HONG PHONE NO : 604 522 1619 1629 FOSTERS WAY SE DECISION MADE: 03-JAN-00 DELTA, B.C., CANADA V3M 6S7 510(k) STATEMENT DEVICE: MD 420/440/460/470/480/490 ISOPURE CORP. 510(k) NO: K993200(TRADITIONAL) ATTN: KEVIN C GILLESPIE PHONE NO : 502-267-7873 11700 COMMONWEALTH DRIVE SE DECISION MADE: 24-JAN-00 SUITE 605 510(k) SUMMARY AVAILABLE FROM FDA LOUISVILLE, KY 40299 DEVICE: ROTARY MASTER J. MORITA USA, INC. 510(k) NO: K992648(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 601 13TH STREET, N.W. SE DECISION MADE: 31-JAN-00 SUITE 500 NORTH 510(k) STATEMENT WASHINGTON, DC 20005 DEVICE: INFRARED EAR THERMOMETER, MODEL KI-8120 K-JUMP HEALTH CO., LTD. 510(k) NO: K984551(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEEN STREET, N.W. SE DECISION MADE: 14-JAN-00 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. PLUS KINETIC CONCEPTS, INC. 510(k) NO: K992448(TRADITIONAL) ATTN: JUDITH A HARBOUR PHONE NO : 210-255-4468 P.O. BOX 659508 SE DECISION MADE: 18-JAN-00 SAN ANTONIO, TX 78265 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITESABER 2000 LASER DENTAL INNOVATIONS 510(k) NO: K993942(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 18-JAN-00 SUIYE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523 DEVICE: ULTRASHAPER KERATOME LASERSIGHT TECHNOLOGIES, INC. 510(k) NO: K990227(TRADITIONAL) ATTN: MICHAEL P DAYTON PHONE NO : 407-678-9900 3300 UNIVERSITY BLVD., #140 SE DECISION MADE: 31-JAN-00 WINTER PARK, FL 32792 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIPO XENON CURING LIGHT LOKKI 510(k) NO: K994028(TRADITIONAL) ATTN: HILLARD W WELCH PHONE NO : 508-771-6777 344 ANNABELLE POINT RD SE DECISION MADE: 12-JAN-00 CENTERVILLE, MA 02632 510(k) STATEMENT DEVICE: TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES LONGBEST (XIAMEN) BALLS CO., LTD 510(k) NO: K993847(TRADITIONAL) ATTN: CHIEN LIN PHONE NO : 773-327-2054 NO. 18 CHIN LIU ST SE DECISION MADE: 18-JAN-00 SHIAUKANG DIST. 510(k) STATEMENT KAOHSIUNG, CHINA (TAIWAN) DEVICE: TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE LONGBEST (XIAMEN) BALLS CO., LTD 510(k) NO: K993849(TRADITIONAL) ATTN: CHIEN LIN PHONE NO : 773-327-2054 NO. 18 CHIN LIU ST SE DECISION MADE: 18-JAN-00 SHIAUKANG DIST. 510(k) STATEMENT KAOHSIUNG, CHINA (TAIWAN) DEVICE: LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBR LPG USA, INC. 510(k) NO: K990445(TRADITIONAL) ATTN: JOCELYNE ROLLAND PHONE NO : 954-569-5005 3101 NORTH FEDERAL HWY. #301 SE DECISION MADE: 18-JAN-00 FORT LAUDERDALE, FL 33306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGSTIM RAPID MAGSTIM CORPORATION US 510(k) NO: K992911(TRADITIONAL) ATTN: REZA JALINOUS PHONE NO : 888-624-7846 730 FIFTH AVE. 9TH FLOOR SE DECISION MADE: 07-JAN-00 NEW YORK, NY 10019 510(k) STATEMENT DEVICE: MANUAL WHEELCHAIR MAJOR MOBILITY PRODUCTS, INC. 510(k) NO: K994185(TRADITIONAL) ATTN: SCOTT SCHWEISS PHONE NO : 281-398-9365 18206 MANCE CT. SE DECISION MADE: 13-JAN-00 HOUSTON, TX 77094 510(k) STATEMENT DEVICE: THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM MDS 510(k) NO: K992727(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 18-JAN-00 NEW YORK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM MEDI-MAN REHABILITATION PRODUCTS I510(k) NO: K992779(TRADITIONAL) ATTN: JOHN T MOGENSEN PHONE NO : 905 565 1480 6200 TOMKEN ROAD SE DECISION MADE: 13-JAN-00 MISSISSAUGA, ONTARIO, CANADA L5T 1510(k) STATEMENT DEVICE: SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. 510(k) NO: K000030(TRADITIONAL) ATTN: GARY J ALLESBROOK PHONE NO : 925-201-1954 6616 OWENS DR. SE DECISION MADE: 19-JAN-00 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISYSTEMS BUTTONHOLE NEEDLE SETS MEDISYSTEMS CORP. 510(k) NO: K990803(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7500 1900 K STREET, N.W. SE DECISION MADE: 06-JAN-00 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUIBAND DENTAL MEDLOGIC GLOBAL CORP. 510(k) NO: K993556(TRADITIONAL) ATTN: STEPHEN J TAMSETT PHONE NO : 800-625-6442 4815 LIST DR., SUITE 111 SE DECISION MADE: 03-JAN-00 COLORADO SPRINGS, CO 80919 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K994208(SPECIAL) ATTN: MARIE HOLM PHONE NO : 612-391-9000 7611 NORTHLAND DR. SE DECISION MADE: 13-JAN-00 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTE MEDTRONIC, INC. 510(k) NO: K994331(SPECIAL) ATTN: NORA K HADDING PHONE NO : 612-514-9500 4000 LEXINGTON AVE. N SE DECISION MADE: 21-JAN-00 SHOREVIEW, MN 55126-2983 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYS MEGA ELECTRONICS LTD. 510(k) NO: K993411(TRADITIONAL) ATTN: DAVID MAHONEY PHONE NO : 413-525-6313 200 NORTH MAIN STREET SE DECISION MADE: 10-JAN-00 SOUTH BUILDING, SUITE 6 510(k) SUMMARY AVAILABLE FROM FDA EAST LONGMEADOW, MA 01028 DEVICE: VACLOK SYRINGE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K994253(SPECIAL) ATTN: CHESTER MCCOY PHONE NO : 801-253-1600 1600 WEST MERIT PKWY. SE DECISION MADE: 05-JAN-00 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993400(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 718-597-3999 1470 OUTLOOK AVE. SE DECISION MADE: 06-JAN-00 BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEGMENTED VAGINAL APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993472(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 718-597-3999 1470 OUTLOOK AVE. SE DECISION MADE: 12-JAN-00 BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS) MICOMED GMBH 510(k) NO: K991862(TRADITIONAL) ATTN: CHARMAINE HENDERSON PHONE NO : 714-525-8441 511 CATALINA ROAD SE DECISION MADE: 13-JAN-00 FULLERTON, CA 92835 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI SM/RNP TEST MICRO DETECT, INC. 510(k) NO: K993635(TRADITIONAL) ATTN: MEHDI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE. SE DECISION MADE: 10-JAN-00 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI SS-A TEST MICRO DETECT, INC. 510(k) NO: K993636(TRADITIONAL) ATTN: MEHDI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE. SE DECISION MADE: 10-JAN-00 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI RF TEST MICRO DETECT, INC. 510(k) NO: K993843(TRADITIONAL) ATTN: MEHDI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE. SE DECISION MADE: 11-JAN-00 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBO MICRO DETECT, INC. 510(k) NO: K993971(TRADITIONAL) ATTN: MEHDI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE. SE DECISION MADE: 11-JAN-00 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI SM TEST MICRO DETECT, INC. 510(k) NO: K994029(TRADITIONAL) ATTN: MEHDI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE. SE DECISION MADE: 11-JAN-00 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 MICRO THERAPEUTICS, INC. 510(k) NO: K993672(SPECIAL) ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 04-JAN-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDMARK M4*9 EASYCLAVE STEAM STERILIZER MIDMARK CORP. 510(k) NO: K992744(TRADITIONAL) ATTN: MIKE SNYDER PHONE NO : 937-526-8390 60 VISTA DR. SE DECISION MADE: 10-JAN-00 P.O. BOX 286 510(k) SUMMARY AVAILABLE FROM FDA VERSAILLES, OH 45380 DEVICE: MILLENNIUM HUBER PLUS SAFETY INFUSION SET MILLENNIUM MEDICAL DISTRIBUTION, I510(k) NO: K993848(TRADITIONAL) ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312 1205 DE LA VINA SE DECISION MADE: 27-JAN-00 SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.0 ML RESERVOIR, MODEL 103/193 MINIMED TECHNOLOGIES, INC. 510(k) NO: K991936(TRADITIONAL) ATTN: JENNIFER LYONS PHONE NO : 818-362-5958 12744 SAN FERNANDO RD. SE DECISION MADE: 18-JAN-00 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HENRY SCHEIN SURGICAL MASK MITSUI TEXTILE CORP. 510(k) NO: K992604(TRADITIONAL) ATTN: WILLIAM J BARONE PHONE NO : 212-827-1034 1450 BROADWAY 22ND FLOOR SE DECISION MADE: 28-JAN-00 NEW YORK, NY 10018 510(k) STATEMENT DEVICE: TRX-CG POWER TILT AND RECLINE SYSTEM MOTION CONCEPTS 510(k) NO: K994241(TRADITIONAL) ATTN: ALLEN BOYD PHONE NO : 416 759 9937 101 BARTLEY DRIVE SE DECISION MADE: 13-JAN-00 TORONTO, ONTARIO, CANADA M4A 1C9 510(k) STATEMENT DEVICE: MTP DISPOSABLE TROCARS MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K994066(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 P.O. BOX 1954 SE DECISION MADE: 20-JAN-00 CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANMA NON-ADJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD. 510(k) NO: K993906(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 31-JAN-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: NANMA AJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD. 510(k) NO: K993908(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 31-JAN-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: NEUROCOMP NEUROCYBERNETICS 510(k) NO: K993654(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD SE DECISION MADE: 27-JAN-00 SUITE 200 510(k) STATEMENT GREAT NECK, NY 11021 DEVICE: MODEL 1000 HOLMIUM LASER SYSTEM NEW STAR LASERS, INC. 510(k) NO: K994273(TRADITIONAL) ATTN: DONALD V JOHNSON PHONE NO : 530-823-1434 11802 KEMPER RD. SE DECISION MADE: 20-JAN-00 AUBURN, CA 95603 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PE 501 PC-ECG MONITOR NHE CORPORATION 510(k) NO: K992584(TRADITIONAL) ATTN: SHUGEN ZHANG PHONE NO : 804-755-1633 7100 FERNWOOD AVE SE DECISION MADE: 13-JAN-00 SUITE 1922 510(k) SUMMARY AVAILABLE FROM FDA RICHMOND, VA 23228 DEVICE: NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES NIHON KOHDEN AMERICA, INC. 510(k) NO: K992455(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-250-3959 2601 CAMPUS DR. SE DECISION MADE: 07-JAN-00 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO LUER ADAPTOR NIPRO MEDICAL CORP. 510(k) NO: K992729(TRADITIONAL) ATTN: KAELYN HADLEY PHONE NO : 606-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 13-JAN-00 LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE NOBEL BIOCARE USA, INC. 510(k) NO: K993595(TRADITIONAL) ATTN: JEFF HAUSHEER PHONE NO : 714-282-4800 22725 SAVI RANCH PKWY. SE DECISION MADE: 28-JAN-00 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K993778(SPECIAL) ATTN: CASEY KUREK PHONE NO : 847-608-8900 600 CHURCH RD. SE DECISION MADE: 06-JAN-00 ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITP, MODEL 1.0 NUCLETRON CORP. 510(k) NO: K992434(TRADITIONAL) ATTN: RALPH E SHUPING PHONE NO : 410-312-4100 7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 13-JAN-00 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OHMEDA MEDICAL OMNIBED OHMEDA MEDICAL 510(k) NO: K993407(TRADITIONAL) ATTN: ALBERTO F PROFUMO PHONE NO : 410-381-4004 9065 GUILFORD RD. SE DECISION MADE: 05-JAN-00 COLUMBIA, MD 21046-1801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 OLYMPUS DIAGNOSTICA GMBH 510(k) NO: K994189(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 20-JAN-00 MELVILLE, NY 11747 510(k) STATEMENT DEVICE: OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYME OMNIGRACE LTD. 510(k) NO: K994246(TRADITIONAL) ATTN: WILLIAM E PATTON PHONE NO : 330-966-8878 7815 VANDERBILT DRIVE NW SE DECISION MADE: 31-JAN-00 NORTH CANTON, OH 44720 510(k) STATEMENT DEVICE: ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES ORATEC INTERVENTIONS, INC. 510(k) NO: K994333(SPECIAL) ATTN: SHEILA RAMERMAN PHONE NO : 650-369-9904 3700 HAVEN CT. SE DECISION MADE: 18-JAN-00 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSI TITANIUM ANEURYSM CLIP PACIFIC SURGICAL INNOVATIONS, INC.510(k) NO: K991959(TRADITIONAL) ATTN: TERRY JOHNSTON PHONE NO : 650-802-6988 360 INDUSTRIAL RD., UNIT H SE DECISION MADE: 06-JAN-00 SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL HANDPIECE PAULINE M. NICHOLLS 510(k) NO: K971732(TRADITIONAL) ATTN: PAULINE M NICHOLLS PHONE NO : 770-267-7963 321 SOUTH BROAD STREET SE DECISION MADE: 11-JAN-00 MONROE, GA 30655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARELISA TPO ANTIBODIES, MODEL 12348/12396 PHARMACIA & UPJOHN CO. 510(k) NO: K993585(TRADITIONAL) ATTN: KAREN E MATIS PHONE NO : 614-794-3324 5094 ST. ANDREWS DRIVE SE DECISION MADE: 05-JAN-00 WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K993377(TRADITIONAL) ATTN: MARGO ENRIGHT PHONE NO : 7736 ZIONSVILLE RD. SE DECISION MADE: 13-JAN-00 INDIANAPOLIS, IN 46268 510(k) STATEMENT DEVICE: SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 PRECISION DYNAMICS CORP. 510(k) NO: K994263(TRADITIONAL) ATTN: KALYNA SNYLYK PHONE NO : 818-897-1111 13880 DEL SUR ST. SE DECISION MADE: 24-JAN-00 SAN FERNANDO, CA 91340-3490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K994224(TRADITIONAL) ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927 3735 WEST BELMONT AVE. SE DECISION MADE: 31-JAN-00 CHICAGO, IL 60618 510(k) STATEMENT DEVICE: UNSENTED INTERLABIAL MENSTRUAL PAD PROCTER & GAMBLE CO. 510(k) NO: K993870(TRADITIONAL) ATTN: MARK M ANDERSON PHONE NO : 513-634-5196 6100 CENTER HILL AVE. SE DECISION MADE: 18-JAN-00 CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMATED CORE BIOPSY DEVICE PROMEX, INC. 510(k) NO: K994272(TRADITIONAL) ATTN: JOSEPH L MARK PHONE NO : 317-736-0128 3049 HUDSON STREET SE DECISION MADE: 07-JAN-00 FRANKLIN, IN 46131 510(k) STATEMENT DEVICE: PURE WATER, INC.'S WATER PURIFICATION SYSTEMS PURE WATER, INC. 510(k) NO: K992786(TRADITIONAL) ATTN: CYNTHIA P WALTERS PHONE NO : 864-375-0105 305 WEST MARKET STREET SE DECISION MADE: 24-JAN-00 ANDERSON, SC 29624 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH PURE WATER, INC. 510(k) NO: K993058(TRADITIONAL) ATTN: RHONDA S MCCOY PHONE NO : 864-375-0105 305 WEST MARKET STREET SE DECISION MADE: 24-JAN-00 ANDERSON, SC 29624 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE RADIOMETER AMERICA, INC. 510(k) NO: K992859(SPECIAL) ATTN: VINCENT M SIGMUND PHONE NO : 440-871-8900 810 SHARON DR. SE DECISION MADE: 10-JAN-00 WESTLAKE, OH 44145-1598 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAFREEZE RHEALM PHARMACEUTICALS, INC. 510(k) NO: K992286(TRADITIONAL) ATTN: RICHARD MANN PHONE NO : 561-736-1880 258 SE 6TH AVE., SUITE 12 SE DECISION MADE: 21-JAN-00 DELRAY BEACH, FL 33483 510(k) STATEMENT DEVICE: RHIGENE ANA ELISA TEST SYSTEM RHIGENE, INC 510(k) NO: K994071(TRADITIONAL) ATTN: DAVE KOLESAR PHONE NO : 847-375-9091 455 STATE ST., SE DECISION MADE: 18-JAN-00 SUITE 104 510(k) STATEMENT DES PLAINES, IL 60068 DEVICE: ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR CO ROCHE DIAGNOSTICS CORP. 510(k) NO: K992851(TRADITIONAL) ATTN: LUANN OCHS PHONE NO : 317-845-2000 9115 HAGUE RD. SE DECISION MADE: 14-JAN-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 ROCHE DIAGNOSTICS CORP. 510(k) NO: K994017(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 27-JAN-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 ROCHE DIAGNOSTICS CORP. 510(k) NO: K994020(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 27-JAN-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONTRAK TESTCUP 5, CAT. 07 6481 7 ROCHE DIAGNOSTICS CORP. 510(k) NO: K994030(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE RD. SE DECISION MADE: 27-JAN-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 ROSSMAX INTL. LTD. 510(k) NO: K993426(SPECIAL) ATTN: MICHAEL YEH PHONE NO : 011 886 27835584 2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 07-JAN-00 SECTION 3, NAN KANG ROAD 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 ROSSMAX INTL. LTD. 510(k) NO: K993429(SPECIAL) ATTN: MICHAEL YEH PHONE NO : 011 886 27835584 2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 07-JAN-00 SECTION 3, NAN KANG ROAD 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 ROSSMAX INTL. LTD. 510(k) NO: K993460(SPECIAL) ATTN: MICHAEL YEH PHONE NO : 011 886 2783 2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 11-JAN-00 SECTION 3, NAN KANG ROAD 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: MRP-TITAN ROTEC MEDIZINTECHNIK GMBH 510(k) NO: K992403(TRADITIONAL) ATTN: ING ULRICH HOLZWARTH PHONE NO : 499 135 3215 AM MUHLBERG 31 SE DECISION MADE: 21-JAN-00 WEISENDORF, GERMANY D-91084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES SAFESKIN CORP. 510(k) NO: K994081(TRADITIONAL) ATTN: EUGENE V GOORCHENKO PHONE NO : 858-509-7010 12671 HIGH BLUFF DR. SE DECISION MADE: 18-JAN-00 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE F SAGE BIOPHARMA 510(k) NO: K991390(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 18-JAN-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: SALTER AIRE COMPRESSOR SALTER LABS 510(k) NO: K992285(TRADITIONAL) ATTN: DUANE KAZAL PHONE NO : 805-854-3166 100 W. SYCAMORE ROAD SE DECISION MADE: 07-JAN-00 ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOSENSE, MODEL 29-8010 SDI DIAGNOSTICS, INC. 510(k) NO: K990962(TRADITIONAL) ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033 10 HAMPDEN DR. SE DECISION MADE: 07-JAN-00 EASTON, MA 02375 510(k) STATEMENT DEVICE: SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT SHANGHAI GLOVMAX ENTERPRISE CO.,LT510(k) NO: K993859(TRADITIONAL) ATTN: MAO-SHENG LEE PHONE NO : 886 225 462479 NANKING E. RD., SEC 3 SE DECISION MADE: 12-JAN-00 TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT SHANGHAI GLOVMAX ENTERPRISE CO.,LT510(k) NO: K993880(TRADITIONAL) ATTN: MAO-SHENG LEE PHONE NO : 886 227 136677ET23 NANKING E. RD., SEC 3 SE DECISION MADE: 12-JAN-00 TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMI SHINEMOUND ENTERPRISE, INC. 510(k) NO: K994248(TRADITIONAL) ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING RD. SE DECISION MADE: 28-JAN-00 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINA SHINEMOUND ENTERPRISE, INC. 510(k) NO: K994258(TRADITIONAL) ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING RD. SE DECISION MADE: 20-JAN-00 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: MAGNETOM OPEN VIVA WITH PERMANENT MAGNET SIEMENS MEDICAL CORP. 510(k) NO: K994316(SPECIAL) ATTN: JAMIE YIEH PHONE NO : 732-321-4625 186 WOOD AVE. SO. SE DECISION MADE: 14-JAN-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMEMNS INFINITY ETC02 POD SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K992116(TRADITIONAL) ATTN: PENELOPE H GRECCO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 12-JAN-00 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA MANUAL WHEELCHAIR SIGMA DISTRIBUTION & SUPPLY, INC. 510(k) NO: K993963(TRADITIONAL) ATTN: ARTHUR KESHISHYAN PHONE NO : 818-246-4624 701 WEST HARVARD STREET SE DECISION MADE: 13-JAN-00 GLENDALE, CA 91204 510(k) STATEMENT DEVICE: PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM SIMS DELTEC, INC. 510(k) NO: K994216(TRADITIONAL) ATTN: LISA STONE PHONE NO : 651-628-7224 1265 GREY FOX RD. SE DECISION MADE: 27-JAN-00 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPO SIMS PORTEX, INC. 510(k) NO: K991861(TRADITIONAL) ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 18-JAN-00 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIORCI SCREW SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K992396(TRADITIONAL) ATTN: DEMETRIOS TSAKONAS PHONE NO : 508-261-3775 130 FORBES BOULEVARD SE DECISION MADE: 12-JAN-00 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOX ALUMINA CERAMIC FEMORAL HEAD SMITH & NEPHEW, INC. 510(k) NO: K991162(ABBREVIATED) ATTN: DAVID HENLEY PHONE NO : 901-396-2121 1450 E. BROOKS ROAD SE DECISION MADE: 28-JAN-00 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES SMITH & NEPHEW, INC. 510(k) NO: K994084(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1494 160 DASCOMB RD. SE DECISION MADE: 20-JAN-00 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 SPACELABS MEDICAL, INC. 510(k) NO: K992749(TRADITIONAL) ATTN: NANCY GERTLAR PHONE NO : 425-867-7315 15220 NORTH EAST 40TH ST. SE DECISION MADE: 14-JAN-00 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAUTERY GRASPER/DISSECTOR STARION INSTRUMENTS 510(k) NO: K994019(TRADITIONAL) ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773 20665 4TH ST. SE DECISION MADE: 20-JAN-00 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTEC STELLARTECH RESEARCH CORP. 510(k) NO: K994173(ABBREVIATED) ATTN: JAMES R SANTOS PHONE NO : 408-331-3000 1346 BORDEAUX DR. SE DECISION MADE: 20-JAN-00 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XE CHECK STRECK LABORATORIES, INC. 510(k) NO: K994388(TRADITIONAL) ATTN: PAUL KITTELSON PHONE NO : 402-691-7465 14124 INDUSTRIAL RD. SE DECISION MADE: 14-JAN-00 OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX STRYKER CORP. 510(k) NO: K993239(TRADITIONAL) ATTN: NICOLE PETTY PHONE NO : 616-323-7700 4100 EAST MILHAM AVENUE SE DECISION MADE: 18-JAN-00 KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS SULZER MEDICA 510(k) NO: K993667(TRADITIONAL) ATTN: EDWARD E NEWTON PHONE NO : 512-435-3407 1300 EAST ANDERSON LANE SE DECISION MADE: 28-JAN-00 AUSTIN, TX 78752-1793 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES SUPERMAX SDN BHD 510(k) NO: K993864(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 657 2328 LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 20-JAN-00 BUKIT RAHMAN PUTRA 510(k) STATEMENT 47000 SUNGAI BULOH SELANGOR, MALAYSIA DEVICE: GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES SUPERMAX SDN BHD 510(k) NO: K993865(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 657 2328 LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 20-JAN-00 BUKIT RAHMAN PUTRA 510(k) STATEMENT 47000 SUNGAI BULOH SELANGOR, MALAYSIA DEVICE: RIM-FIX, ACETABULAR CUP SURGICAL IMPLANTS, INC. 510(k) NO: K993713(TRADITIONAL) ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882 962 SOUTH TAMIAMI TRAIL, #203 SE DECISION MADE: 28-JAN-00 SARASOTA, FL 34326 510(k) STATEMENT DEVICE: PHARMASEED, MODEL BT-103-1 SYNCOR PHARMACEUTICALS, INC. 510(k) NO: K992007(TRADITIONAL) ATTN: GARY GILMORE PHONE NO : 303-279-1014 1313 WASHINGTON AVENUE SE DECISION MADE: 14-JAN-00 GOLDEN, CO 80401 510(k) STATEMENT DEVICE: ABBOTT AEROSET PHENYTOIN ASSAY AND CALIBRATORS; MODELS 1E07 AND SYVA CO. 510(k) NO: K993026(TRADITIONAL) ATTN: PAUL L ROGERS JR. PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 SYVA CO. 510(k) NO: K993028(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 A SYVA CO. 510(k) NO: K993029(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 A SYVA CO. 510(k) NO: K993031(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C12 SYVA CO. 510(k) NO: K993982(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL SYVA CO. 510(k) NO: K993983(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL SYVA CO. 510(k) NO: K993984(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 18-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL SYVA CO. 510(k) NO: K993985(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL SYVA CO. 510(k) NO: K993986(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL SYVA CO. 510(k) NO: K993987(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL SYVA CO. 510(k) NO: K993988(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL SYVA CO. 510(k) NO: K994005(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 20-JAN-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: GOWN BACK, MODEL 13-403N; 13-404N; 13-405N TECHSTYLES, INC. 510(k) NO: K992436(TRADITIONAL) ATTN: STEPHANIE T HOWARD PHONE NO : 972-732-7694 16415 ADDISON RD., SUITE 850 SE DECISION MADE: 20-JAN-00 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND TECO DIAGNOSTICS 510(k) NO: K000067(SPECIAL) ATTN: DINDO CARRILLO PHONE NO : 714-693-7788 4925 EAST HUNTER AVE. SE DECISION MADE: 20-JAN-00 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: TFX MEDICAL INTRODUCER KIT TFX MEDICAL GROUP 510(k) NO: K991647(TRADITIONAL) ATTN: JULIE A BEAUMONT PHONE NO : 603-532-7706 TALL PINES PARK SE DECISION MADE: 04-JAN-00 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX CONDOM THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K994095(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-7040 1219 LITTLE CREEK RD. SE DECISION MADE: 18-JAN-00 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KERLIX MD ANTIMICROBIAL GAUZE DRESSING THE KENDALL COMPANY, L.P. 510(k) NO: K990530(TRADITIONAL) ATTN: DAVID A OLSON PHONE NO : 508-261-8530 15 HAMPSHIRE ST. SE DECISION MADE: 31-JAN-00 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM THERASENSE, INC. 510(k) NO: K992684(TRADITIONAL) ATTN: EVE A CONNER PHONE NO : 510-749-5400 1360 SOUTH LOOP DRIVE SE DECISION MADE: 14-JAN-00 ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES TOP GLOVE SDN. BHD. 510(k) NO: K993664(TRADITIONAL) ATTN: WEE-CHAI LIM PHONE NO : 603 392 19921905 LOT 4968 JALAN TERATAI, BATU 6 SE DECISION MADE: 11-JAN-00 OFFJALAN MERU, 41050 KLANG 510(k) STATEMENT SELANGOR, D.E., MALAYSIA DEVICE: OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON TOSHIBA AMERICA MRI, INC. 510(k) NO: K993574(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 18-JAN-00 SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENA PROFILE ELISA TEST SYSTEM TRINITY BIOTECH USA 510(k) NO: K993839(TRADITIONAL) ATTN: WAYNE KVETKOSKY PHONE NO : 716-483-3851 2823 GIRTS RD. SE DECISION MADE: 12-JAN-00 JAMESTOWN, NY 14702 510(k) STATEMENT DEVICE: UNIGRAFT UNICARE BIOMEDICAL 510(k) NO: K993784() ATTN: STAN YANG PHONE NO : 949-362-1772 25951 LA CUESTA AVENUE SE DECISION MADE: 27-JAN-00 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHASED ARRAY KNEE AND FOOT COIL USA INSTRUMENTS, INC. 510(k) NO: K994040(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 18-JAN-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARP 9000 PHASED ARRAY BRAIN COIL USA INSTRUMENTS, INC. 510(k) NO: K994042(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 31-JAN-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEMAITRE BILIARY CATHETER VASCUTECH, INC. 510(k) NO: K992941(TRADITIONAL) ATTN: TRENT G KAMKE PHONE NO : 781-221-2266 164 MIDDLESEX TURNPIKE SE DECISION MADE: 12-JAN-00 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTI VIDAR SYSTEMS CORP. 510(k) NO: K993598(TRADITIONAL) ATTN: MARY "PENNIE" DRINKARD PHONE NO : 703-471-7070 460 SPRING PARK PL. SE DECISION MADE: 20-JAN-00 HERNDON, VA 20170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMET VIDAR SYSTEMS CORP. 510(k) NO: K993599(TRADITIONAL) ATTN: MARY "PENNIE" DRINKARD PHONE NO : 703-471-7070 460 SPRING PARK PL. SE DECISION MADE: 18-JAN-00 HERNDON, VA 20170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYS VIRGINIA WATER SYSTEMS, INC. 510(k) NO: K991916(TRADITIONAL) ATTN: WILLIAM G GARRAHAN PHONE NO : 804-743-0034 7433 WHITEPINE RD. SE DECISION MADE: 14-JAN-00 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UFI GEL HARD VOCO GMBH 510(k) NO: K993827(TRADITIONAL) ATTN: SHUOJIA DONG PHONE NO : 450 646 1330 4235 BEACONSFIELD SE DECISION MADE: 20-JAN-00 MONTREAL, CANADA QC,H4A 2H4 510(k) STATEMENT DEVICE: ADMIRA VOCO GMBH 510(k) NO: K994056(TRADITIONAL) ATTN: EVAN DICK PHONE NO : 314-721-0112 7527 WESTMORELAND AVE. SE DECISION MADE: 12-JAN-00 ST. LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STA WAKO CHEMICALS, USA, INC. 510(k) NO: K993924(TRADITIONAL) ATTN: TONYA MALLORY PHONE NO : 800-992-9256 1600 BELLWOOD RD. SE DECISION MADE: 14-JAN-00 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN ST WAKO CHEMICALS, USA, INC. 510(k) NO: K993927(TRADITIONAL) ATTN: TONYA MALLORY PHONE NO : 800-992-9256 1600 BELLWOOD RD. SE DECISION MADE: 14-JAN-00 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STA WAKO CHEMICALS, USA, INC. 510(k) NO: K993928(TRADITIONAL) ATTN: TANYA MALLORY PHONE NO : 800-992-9256 1600 BELLWOOD RD. SE DECISION MADE: 18-JAN-00 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT NITRILE EXAMINATION GLOVES (POWDERED) WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K992675(TRADITIONAL) ATTN: CLAUDE COTTET PHONE NO : 03 376 3525 LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 20-JAN-00 NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT PORT KLANG, SELANGOR, D.E., MALAYSIA 42000 DEVICE: OSOM ULTRA STREP A TEST, MODEL 147 WYNTEK DIAGNOSTICS, INC. 510(k) NO: K992658(TRADITIONAL) ATTN: SHU-CHING CHENG PHONE NO : 858-452-3198 6146 NANCY RIDGE DR., SE DECISION MADE: 18-JAN-00 SUITE 101 510(k) STATEMENT SAN DIEGO, CA 92121 DEVICE: XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWER XOMED, INC. 510(k) NO: K992855(TRADITIONAL) ATTN: DAVID TIMLIN PHONE NO : 904-279-7532 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 21-JAN-00 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LASER-SHIELD II XOMED, INC. 510(k) NO: K993582(TRADITIONAL) ATTN: ROY BERENS PHONE NO : 904-296-6454 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 20-JAN-00 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 283 TOTAL WITH SUMMARIES 200 TOTAL WITH STATEMENTS 83
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