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510(k)s Final Decisions Rendered for April 2002 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-APR-2002 THROUGH 30-APR-2002 DEVICE: IMMEDIATE STABILIZING DEVICE (ISD) "O" CO., INC. 510(k) NO: K011524(TRADITIONAL) ATTN: DAVID D DALISE PHONE NO : 800-228-0477 600 PAISANO, N.E., SUITE A SE DECISION MADE: 10-APR-02 ALBUQUERQUE, NM 87123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE 3M CO. 510(k) NO: K020589(TRADITIONAL) ATTN: JOANN L HUEHN PHONE NO : 651-733-9209 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 22-APR-02 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADPER PROMPT 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K020946(SPECIAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 04-APR-02 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APC PLUS ADHESIVE 3M UNITEK 510(k) NO: K020394(TRADITIONAL) ATTN: MARLYN SCHEFF PHONE NO : 626-574-4496 2724 SOUTH PECK RD. SE DECISION MADE: 12-APR-02 MONROVIA, CA 91016 510(k) STATEMENT DEVICE: ETEST ERTAPENEM AB BIODISK 510(k) NO: K020748(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0768 DALVAGEN 10 SE DECISION MADE: 29-APR-02 SOLNA, SWEDEN S-169 56 510(k) STATEMENT DEVICE: MOTION TRACKING ACCURAY, INC. 510(k) NO: K020294(TRADITIONAL) ATTN: DONALD E CADDES PHONE NO : 408-522-3740 570 DEL REY AVE. SE DECISION MADE: 22-APR-02 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACIST PLUS 4 ANGIOGRAPHIC CATHETER ACIST MEDICAL SYSTEMS 510(k) NO: K021015(SPECIAL) ATTN: CARL M BEAURLINE PHONE NO : 612-995-9319 7450 FLYING CLOUDS DR. SE DECISION MADE: 26-APR-02 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA EDEN PRAIRIE, MN 55344 DEVICE: H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MOD ACKRAD LABORATORIES 510(k) NO: K020951(SPECIAL) ATTN: RICHARD HETTENBACH PHONE NO : 908-276-6390 70 JACKSON DR. SE DECISION MADE: 16-APR-02 CRANFORD, NJ 07016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPH ACKRAD LABORATORIES 510(k) NO: K020954(SPECIAL) ATTN: RICHARD HETTENBACH PHONE NO : 908-276-6390 70 JACKSON DR. SE DECISION MADE: 24-APR-02 CRANFORD, NJ 07016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE ADVANCED HEALTHCARE LTD. 510(k) NO: K020376(TRADITIONAL) ATTN: PERRY KASHFIAN PHONE NO : 818-362-2600 13161 TELFAIR AVE. SE DECISION MADE: 09-APR-02 SYLMAR, CA 91342 510(k) STATEMENT DEVICE: REPROCESSED USED DISPOSABLE BIOPSY FORCEPS ADVEN MEDICAL 510(k) NO: K012699(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 17-APR-02 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPILOT 2 AESCULAP, INC. 510(k) NO: K013569(TRADITIONAL) ATTN: GEORG KELLER PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 04-APR-02 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIETHKE SHUNT SYSTEM AESCULAP, INC. 510(k) NO: K020728(SPECIAL) ATTN: JOYCE KILROY PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 05-APR-02 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 ALBA-WALDENSIAN, INC. 510(k) NO: K020592(TRADITIONAL) ATTN: DAVID BOWMAN PHONE NO : 865-354-0410 425 NORTH GATEWAY AVE SE DECISION MADE: 03-APR-02 ROCKWOOD, TN 37854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTICHROME HEPARIN (ANTI-FIIA) AMERICAN DIAGNOSTICA, INC. 510(k) NO: K013637(TRADITIONAL) ATTN: JOHN BERRYMAN PHONE NO : 203-661-0000 222 RAILROAD AVE. SE DECISION MADE: 16-APR-02 GREENWICH, CT 06830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY APEX DENTAL MATERIALS, INC. 510(k) NO: K020570(TRADITIONAL) ATTN: CHRIS KULTON PHONE NO : 847-490-1014 603 BERKLEY COURT SE DECISION MADE: 24-APR-02 SCHAUMBURG, IL 60194 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHECKCUP IMMUNOASSAY SYSTEM FOR DRUGS OF ABUSE APPLIED BIOTECH, INC. 510(k) NO: K021093(SPECIAL) ATTN: STEVE WORCESTER PHONE NO : 858-587-6771 10237 FLANDERS CT. SE DECISION MADE: 24-APR-02 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: WOUND PROTECTOR/RETRACTOR APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K020435(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-713-8327 22872 AVENIDA EMPRESSA SE DECISION MADE: 15-APR-02 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LA AR ALLIANCE HEALTHCARE SDN. BHD. 510(k) NO: K020838(TRADITIONAL) ATTN: CHAU CHOON CHUAN PHONE NO : 60 04 5937616 8, LORONG INDUSTRI 11, KAWASAN SE DECISION MADE: 23-APR-02 PERINDUSTRIAN BUKIT PANCHOR, 510(k) STATEMENT NIBONG TEBAL, PULAU PINANG, MALAYSIA 14300 DEVICE: CARIS MINITOME BIOPSY INSTRUMENT ARTEMIS MEDICAL, INC. 510(k) NO: K020024(TRADITIONAL) ATTN: ALLAN L ABATI PHONE NO : 510-259-3150 21021 CORSAIR BLVD. SE DECISION MADE: 03-APR-02 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHR ARTHREX, INC. 510(k) NO: K020043(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 02-APR-02 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER COR ARTHROCARE CORP. 510(k) NO: K020832(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 09-APR-02 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RH ATRICURE, INC. 510(k) NO: K020919(SPECIAL) ATTN: MARK L FRIEDMAN PHONE NO : 513-755-4105 6033 SCHUMACHER PARK DRIVE SE DECISION MADE: 19-APR-02 WEST CHESTER, OHIO, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRION MEDICAL QL FLUID DISPENSING SYRINGE ATRION MEDICAL PRODUCTS, INC. 510(k) NO: K020333(TRADITIONAL) ATTN: DAN CLARK PHONE NO : 256-586-1580 1426 CURT FRANCIS RD. SE DECISION MADE: 25-APR-02 ARAB, AL 35016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTA SST BIFURCATED GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K020767(SPECIAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 03-APR-02 HUDSON, NH 03051 510(k) STATEMENT DEVICE: BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM AZARY TECHNOLOGIES LLC. 510(k) NO: K013672(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 08-APR-02 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL LE BARCO NV 510(k) NO: K020058(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 04-APR-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MFCD 118I BARCO NV 510(k) NO: K020059(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 03-APR-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGEDESK BARCO NV 510(k) NO: K020061(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 03-APR-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB INCORPORATED 510(k) NO: K013762(TRADITIONAL) ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638 1400 N. GOODMAN STREET SE DECISION MADE: 03-APR-02 PO BOX 30450 510(k) SUMMARY AVAILABLE FROM FDA ROCHESTER, NY 14603-0450 DEVICE: GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) BAYER GROUP DIAGNOSTICS 510(k) NO: K020208(TRADITIONAL) ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928 1884 MILES AVENUE SE DECISION MADE: 29-APR-02 P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46515-0070 DEVICE: GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) BAYER GROUP DIAGNOSTICS 510(k) NO: K020210(TRADITIONAL) ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928 1884 MILES AVENUE SE DECISION MADE: 30-APR-02 P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA ELKHART, IN 46515-0070 DEVICE: BCI 3180 PULSE OXIMETER BCI, INC. 510(k) NO: K020350(TRADITIONAL) ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100 N7 W22025 JOHNSON ROAD SE DECISION MADE: 30-APR-02 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 BECTON DICKINSON INFUSION THERAPY 510(k) NO: K013621(TRADITIONAL) ATTN: LESLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE ST. SE DECISION MADE: 16-APR-02 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACTEC MGIT 960 SIRE KITS BECTON, DICKINSON AND COMPANY 510(k) NO: K014123(TRADITIONAL) ATTN: JODY J HOFFMANN PHONE NO : 410-316-4192 7 LOVETON CIR. SE DECISION MADE: 19-APR-02 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON AND COMPANY 510(k) NO: K020323(TRADITIONAL) ATTN: BRADFORD M SPRING PHONE NO : 410-316-4206 7 LOVETON CIR. SE DECISION MADE: 04-APR-02 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYMPHA VISION-EXPERT BEXLEY TRADING, INC. 510(k) NO: K003896(ABBREVIATED) ATTN: MICHAEL ZMUDA PHONE NO : 1105 BUCKBRUSH DR SE DECISION MADE: 24-APR-02 FOLSOM, CA 95630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 BIO-RAD 510(k) NO: K020610(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 949-598-1200 9500 JERONIMO ROAD SE DECISION MADE: 22-APR-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK HEMOSTASIS, MODELS 798, 799 BIO-RAD 510(k) NO: K020878(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367 9500 JERONIMO ROAD SE DECISION MADE: 15-APR-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD LABORATORIES, INC. 510(k) NO: K020817(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200 9500 JERONIMO ROAD SE DECISION MADE: 12-APR-02 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC. 510(k) NO: K020099(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 11-APR-02 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT FA CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K020813(TRADITIONAL) ATTN: RON SANYAL PHONE NO : 919-620-2373 100 RODOLPHE STREET SE DECISION MADE: 17-APR-02 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT FN CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K020815(TRADITIONAL) ATTN: RON SANYAL PHONE NO : 919-620-2373 100 RODOLPHE STREET SE DECISION MADE: 18-APR-02 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT PF CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K020923(TRADITIONAL) ATTN: RON SANYAL PHONE NO : 919-620-2373 100 RODOLPHE STREET SE DECISION MADE: 18-APR-02 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT SA CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K020931(TRADITIONAL) ATTN: RON SANYAL PHONE NO : 919-620-2373 100 RODOLPHE STREET SE DECISION MADE: 18-APR-02 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT SN CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K021123(TRADITIONAL) ATTN: RON SANYAL PHONE NO : 919-620-2373 100 RODOLPHE STREET SE DECISION MADE: 26-APR-02 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020221(TRADITIONAL) ATTN: LOMNIE WITHAM PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 02-APR-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NBX - NON-BRIDGING EXTERNAL FIXATOR BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020905(SPECIAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 15-APR-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FE BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020963(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 16-APR-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER TEK II BIOMET, INC. 510(k) NO: K020761(SPECIAL) ATTN: PATRICIA S BERES PHONE NO : 574-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 03-APR-02 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0578 DEVICE: DISTAL RADIUS PLATING SYSTEM BIOMET, INC. 510(k) NO: K020819(TRADITIONAL) ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 22-APR-02 WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) BIOMET, INC. 510(k) NO: K020970(SPECIAL) ATTN: TRACY J BICKEL PHONE NO : 574-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 04-APR-02 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0578 DEVICE: SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT BIOSAFE LABORATORIES, INC. 510(k) NO: K012221(TRADITIONAL) ATTN: JACK A MAGGIORE PHONE NO : 773-693-0400 100 FIELD DRIVE #240 SE DECISION MADE: 03-APR-02 LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF BIOSOUND ESAOTE, INC. 510(k) NO: K014168(TRADITIONAL) ATTN: COLLEEN H DENSMORE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 25-APR-02 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABP-2000 G-3 BIOTRAC, INC. 510(k) NO: K021029(TRADITIONAL) ATTN: JAIME GUTTMAN PHONE NO : 305-594-7474 7215 N.W. 46TH STREET SE DECISION MADE: 12-APR-02 MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP BIOTRONIK, INC. 510(k) NO: K010281(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 09-APR-02 LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIRD TBIRD VELA VENTILATOR BIRD PRODUCTS CORP. 510(k) NO: K020746(SPECIAL) ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255 1100 BIRD CENTER DR. SE DECISION MADE: 22-APR-02 PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW BLACKSTONE MEDICAL, INC. 510(k) NO: K020674(TRADITIONAL) ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968 90 BROOKSDALE DR. SE DECISION MADE: 03-APR-02 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLADEWORKS MICROKERATOME BLADE, MODEL 7061 BLADE WORKS, INC. 510(k) NO: K020079(TRADITIONAL) ATTN: MARK MOYER PHONE NO : 760-471-2427 1816 TOWHEE STREET SE DECISION MADE: 19-APR-02 SAN MARCOS, CA 92069 510(k) STATEMENT DEVICE: MODIFICATION TO TRELEX MESH SURGICAL MESH BOSTON SCIENTIFIC CORP. 510(k) NO: K020110(ABBREVIATED) ATTN: LORRAINE M HANLEY PHONE NO : 508-650-8172 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 03-APR-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 A BOSTON SCIENTIFIC CORP. 510(k) NO: K020765(TRADITIONAL) ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 05-APR-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER BOSTON SCIENTIFIC CORP. 510(k) NO: K020824(SPECIAL) ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 12-APR-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBRA COOLED SURGICAL PROBE, MODEL 1596X BOSTON SCIENTIFIC CORP. 510(k) NO: K021046(SPECIAL) ATTN: SUSAN POOL PHONE NO : 408-985-3608 2710 ORCHARD PKWY. SE DECISION MADE: 16-APR-02 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR BOSTON SCIENTIFIC CORP. 510(k) NO: K021213(SPECIAL) ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 19-APR-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIN CARE 4200 BREG, INC. 510(k) NO: K020988(SPECIAL) ATTN: KATHLEEN BARBER PHONE NO : 760-599-3000 2611 COMMERCE WAY SE DECISION MADE: 04-APR-02 VISTA, CA 92083 510(k) STATEMENT DEVICE: BUSSE UMBILICAL CORD CLAMP CUTTER BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K021055(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 29-APR-02 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. 510(k) NO: K020682(SPECIAL) ATTN: CAROL VIERLING PHONE NO : 770-385-2347 13183 HARLAND DR. SE DECISION MADE: 02-APR-02 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROJET MODEL # CD4 AND CD4/20 CANE S.R.I. 510(k) NO: K013776(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 26-APR-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROJET CRONO CANE SRL 510(k) NO: K013234(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 26-APR-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KING OF HEARTS EXPRESS + AF MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K020825(SPECIAL) ATTN: ALDEN KAY PHONE NO : 858-777-2200 6779 MESA RIDGE ROAD SE DECISION MADE: 05-APR-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121-2909 DEVICE: GLOBAL ECG MANAGEMENT SYSTEM (GEMS) CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K020366(TRADITIONAL) ATTN: ANGELA HALWAS PHONE NO : 250 744 1822 3060 CEDAR HILL ROAD SE DECISION MADE: 30-APR-02 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA VICTORIA, B.C., CANADA V8T 3J5 DEVICE: CARDIOVENTION CORX SYSTEM, MODEL FG 0001 CARDIOVENTION, INC. 510(k) NO: K012325(TRADITIONAL) ATTN: TESSA YAMUT PHONE NO : 408-844-5130 3045 STENDER WAY SE DECISION MADE: 09-APR-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE TRGLYCERIDE CARESIDE, INC. 510(k) NO: K020488(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 15-APR-02 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UTERINE INJECTOR CATHETER RESEARCH, INC. 510(k) NO: K020292(TRADITIONAL) ATTN: JOHN A STEEN PHONE NO : 317-872-0074 6131 WEST 80TH STREET SE DECISION MADE: 17-APR-02 INDIANAPOLIS, IN 46278 510(k) STATEMENT DEVICE: EMULATE FAST SET AND EMULATE REGULAR SET CAVEX HOLLAND B.V. 510(k) NO: K020242(TRADITIONAL) ATTN: RICHARD WOORTMAN PHONE NO : 312 353 07700 PO BOX 852 SE DECISION MADE: 17-APR-02 HAARLEM (HOLLAND), NETHERLANDS 200510(k) STATEMENT DEVICE: QAB2A IGM ELISA KIT CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K020694(TRADITIONAL) ATTN: NEIL B STRINGER PHONE NO : 44 151 3488023 MANAGEMENT CENTRE, INWARD WAY SE DECISION MADE: 19-APR-02 ELLESMERE PORT 510(k) STATEMENT CHESHIRE, UNITED KINGDOM CH65 3EN DEVICE: QAB2A IGG ELISA KIT CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K020695(TRADITIONAL) ATTN: NEIL B STRINGER PHONE NO : 44 151 3488023 MANAGEMENT CENTRE, INWARD WAY SE DECISION MADE: 19-APR-02 ELLESMERE PORT 510(k) STATEMENT CHESHIRE, UNITED KINGDOM CH65 3EN DEVICE: ISAAC 1.5 T MR SYSTEM CHI, INC. 510(k) NO: K020268(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 C/O C.L. MCINTOSH SE DECISION MADE: 25-APR-02 12300 TWINBROOK PKWY 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: AQUIFY LENS COMFORT DROPS CIBA VISION CORP. 510(k) NO: K013204(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 03-APR-02 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL D CIBA VISION CORP. 510(k) NO: K020139(TRADITIONAL) ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924 11460 JOHNS CREEK PKWY. SE DECISION MADE: 09-APR-02 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOPEN AND ACCESSORIES CIMEX BIOTECH, LLC. 510(k) NO: K012214(TRADITIONAL) ATTN: MICHAEL HAAS PHONE NO : 504-871-0802 72385 INDUSTRY PARK SE DECISION MADE: 26-APR-02 COVINGTON, LA 70435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC C CIRCON VIDEO 510(k) NO: K012758(TRADITIONAL) ATTN: WAYNE STERNER PHONE NO : 805-685-5100 6500 HOLLISTER AVE. SE DECISION MADE: 09-APR-02 SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMEDICAL/RADI FEMOSTOP COMPRESSION SYSTEM, MODEL 017500 CLEAR MEDICAL, INC. 510(k) NO: K012604(TRADITIONAL) ATTN: RICHARD RADFORD PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 19-APR-02 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPEX SPORT COMPEX S.A. 510(k) NO: K011880(TRADITIONAL) ATTN: ANSIS M HELMANIS PHONE NO : 202-457-0300 1225 EYE STREET, N.W. SE DECISION MADE: 17-APR-02 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONM CONMED CORP. 510(k) NO: K020135(TRADITIONAL) ATTN: CHARLES M HART PHONE NO : 303-699-7600 14603 FREMONT AVE. SE DECISION MADE: 12-APR-02 CENTENNIAL, CO 80112 510(k) STATEMENT DEVICE: CONMED SYSTEM 5000 ESU CONMED CORP. 510(k) NO: K020186(TRADITIONAL) ATTN: CHARLES M (MIKE) HART PHONE NO : 303-699-7600 14603 FREMONT AVE. SE DECISION MADE: 12-APR-02 CENTENNIAL, CO 80112 510(k) STATEMENT DEVICE: STRATASIS SLING KIT COOK BIOTECH, INC. 510(k) NO: K020654(TRADITIONAL) ATTN: MARK BLEYER PHONE NO : 765-497-3355 3055 KENT AVE. SE DECISION MADE: 09-APR-02 WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAMPONADE UTERINE BALLOON CATHETER SET COOK OB/GYN 510(k) NO: K013597(TRADITIONAL) ATTN: CINDY RUMPLE PHONE NO : 812-829-6500 1100 W. MORGAN STREET SE DECISION MADE: 17-APR-02 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE COOK VASCULAR, INC. 510(k) NO: K010128(TRADITIONAL) ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621 P.O. BOX 529 SE DECISION MADE: 25-APR-02 LEECHBURG, PA 15656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIP DEFLRCTING ENDOBRONCHIAL BLOCKER COOK, INC. 510(k) NO: K013865(SPECIAL) ATTN: LISA HOPKINS PHONE NO : 800-346-2686 925 SOUTH CURRY PIKE SE DECISION MADE: 22-APR-02 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS F COOPERVISION, INC. 510(k) NO: K020392(TRADITIONAL) ATTN: BONNIE TSYMBAL PHONE NO : 585-264-3210 711 NORTH RD. SE DECISION MADE: 26-APR-02 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT CORDIS CORP. 510(k) NO: K020809(SPECIAL) ATTN: DONNA MARSHALL PHONE NO : 908-412-3844 7 POWDER HORN DRIVE SE DECISION MADE: 12-APR-02 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNE CELL FUNCTION ASSAY CYLEX, INC. 510(k) NO: K013169(TRADITIONAL) ATTN: JUDI SMITH PHONE NO : 410-592-2060 P.O. BOX 103 SE DECISION MADE: 02-APR-02 BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH AMPIC DADE BEHRING, , INC. 510(k) NO: K020319(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 2040 ENTERPRISE BLVD. SE DECISION MADE: 17-APR-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH PIPER DADE BEHRING, , INC. 510(k) NO: K020397(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 2040 ENTERPRISE BLVD. SE DECISION MADE: 22-APR-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTR DADE MICROSCAN, INC. 510(k) NO: K020506(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 1584 ENTERPRISE BLVD. SE DECISION MADE: 17-APR-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN DADE MICROSCAN, INC. 510(k) NO: K020556(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 26-APR-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN DADE MICROSCAN, INC. 510(k) NO: K020626(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 26-APR-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM DADE MICROSCAN, INC. 510(k) NO: K020686(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 30-APR-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR DADE MICROSCAN, INC. 510(k) NO: K020691(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 30-APR-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUWAVE DAN MED, INC. 510(k) NO: K013210(TRADITIONAL) ATTN: THOMAS SANDGAARD PHONE NO : 800-495-6670 4 WEST DRY CREEK CIRCLE, SE DECISION MADE: 04-APR-02 SUITE 260 510(k) STATEMENT DENVER, CO 80120 DEVICE: DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE CORP. 510(k) NO: K020257(TRADITIONAL) ATTN: JOANN WOLF PHONE NO : 973-244-6123 15 LAW DR. SE DECISION MADE: 24-APR-02 FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAORAL CAMERA ME-15 DENT CORP. RESEARCH & DEVELOPMENT 510(k) NO: K020206(TRADITIONAL) ATTN: DAVID ABELDA PHONE NO : 914-682-6600 7-11 S. BROADWAY SE DECISION MADE: 11-APR-02 WHITE PLAINS, NY 10601 510(k) STATEMENT DEVICE: DEPILASE TWIN YAG LASER SYSTEM DEPILASE GROUP LTD. 510(k) NO: K020697(ABBREVIATED) ATTN: MARIO RUSSO PHONE NO : 442 077 121675 ONE CANADA SQUARE SE DECISION MADE: 12-APR-02 CANARY WHARF 510(k) SUMMARY AVAILABLE FROM FDA LONDON, UNITED KINGDOM E14 5DY THIRD PARTY REVIEW DEVICE: DIASOL-BICARB DIASOL, INC. 510(k) NO: K020230(TRADITIONAL) ATTN: MONICA ABELES PHONE NO : 818-255-1800 13212 RAYMER ST. SE DECISION MADE: 23-APR-02 NORTH HOLLYWOOD, CA 91605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.P.A. 510(k) NO: K020997(SPECIAL) ATTN: BARRY SALL PHONE NO : 781-434-4742 195 WEST STREET SE DECISION MADE: 04-APR-02 WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHIN ELECTRODE DYMEDIX, INC. 510(k) NO: K020468(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 16-APR-02 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "DELTA 2000" SERIES EXTRACORPOREAL LITHOTRIPTER E.S.W.L. PRODUCTS, INC. 510(k) NO: K013471(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 29-APR-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATIC CRANIOPLASTY ORTHOSIS EASTERN CRANIAL AFFILIATES 510(k) NO: K020448(TRADITIONAL) ATTN: JOSEPH TERPENNING PHONE NO : 703-516-4340 2525 NORTH TENTH STREET # 804 SE DECISION MADE: 12-APR-02 ARLINGTON, VA 22201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. 510(k) NO: K020681(SPECIAL) ATTN: PATRICIA FLOOD PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 03-APR-02 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCH ECHOTECH 3D IMAGING SYSTEMS, INC. 510(k) NO: K013088(TRADITIONAL) ATTN: KEVIN MORNINGSTAR PHONE NO : 303-697-8198 PO BOX 218 SE DECISION MADE: 04-APR-02 INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K020918(SPECIAL) ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 902 543 6665 2 COOK RD. SE DECISION MADE: 19-APR-02 BRIDGEWATER, NOVA SCOTIA, CANADA B510(k) STATEMENT DEVICE: AXILLARY ACCESS ARTERIAL CANNULA EDWARDS LIFESCIENCES, LLC. 510(k) NO: K002578(TRADITIONAL) ATTN: KAREN JONES PHONE NO : 801-565-6231 6864 SOUTH 300 WEST SE DECISION MADE: 11-APR-02 MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 EDWARDS LIFESCIENCES, LLC. 510(k) NO: K020864(SPECIAL) ATTN: SUSAN REYNOLDS PHONE NO : 949-250-2482 ONE EDWARDS WAY SE DECISION MADE: 17-APR-02 IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EFILM WORKSTATION WITH MODULES EFILM MEDICAL, INC. 510(k) NO: K020995(TRADITIONAL) ATTN: JOSEPH A THOMAS PHONE NO : 416 204 9664 X291 500 UNIVERSITY AVE., SUITE 300 SE DECISION MADE: 12-APR-02 TORONTO, ONTARIO, CANADA M5G 1V7 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS ELAN DIAGNOSTICS 510(k) NO: K020575(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-672-3553 1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 12-APR-02 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMS ELECTROSTATIC FLITER AND HME COMBINATION ENGINEERED MEDICAL SYSTEMS 510(k) NO: K013122(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 19-APR-02 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRONOMER PLUS SYSTEM EP TECHNOLOGIES, INC. 510(k) NO: K013349(ABBREVIATED) ATTN: ANDREA L RUTH PHONE NO : 408-895-3500 2710 ORCHARD PKWY. SE DECISION MADE: 09-APR-02 SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 ETHICON ENDO-SURGERY, INC. 510(k) NO: K020276(TRADITIONAL) ATTN: GEORGE C ABERNATHY PHONE NO : 513-337-3179 4545 CREEK RD. SE DECISION MADE: 12-APR-02 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVANS SUB-Q, MODEL MC4206 EVANS MEDICAL, INC. 510(k) NO: K020530(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 29-APR-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIALOC DENTAL IMPLANT SYSTEM FRIADENT GMBH 510(k) NO: K013067(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 09-APR-02 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GARAVENTA SUPER-TRAC TRE-52 GARAVENTA ACCESSIBILITY 510(k) NO: K020933(SPECIAL) ATTN: NORM COOPER PHONE NO : 800-663-6556 BOX 1769 SE DECISION MADE: 04-APR-02 BLAIN, WA 98231-1769 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GC FUJI ORTHO BAND PASTE PAK GC AMERICA, INC. 510(k) NO: K020578(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 26-APR-02 ALSIP, IL 60803 510(k) STATEMENT DEVICE: SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 GE MEDICAL SYSTEMS 510(k) NO: K020929(TRADITIONAL) ATTN: PHONE NO : 283 RUE DE LA MINIERE SE DECISION MADE: 03-APR-02 BP 34 510(k) SUMMARY AVAILABLE FROM FDA BUC CEDEX, FRANCE 78533 THIRD PARTY REVIEW DEVICE: OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM GE OEC MEDICAL SYSTEMS 510(k) NO: K021049(TRADITIONAL) ATTN: BILL GISLASON PHONE NO : 801-536-4520 384 WRIGHT BROTHERS DR. SE DECISION MADE: 17-APR-02 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VIVID 3 EXPERT; GE VIVID 3 PRO GENERAL ELECTRIC CO. 510(k) NO: K020789(TRADITIONAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 04-APR-02 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANG GISH BIOMEDICAL, INC. 510(k) NO: K020106(TRADITIONAL) ATTN: JAMES H KNAUSS PHONE NO : 713-723-4080 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 10-APR-02 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL GT980201 ELECTRONIC THERMOMETER GLOBAL TREASURE LTD. 510(k) NO: K021028(TRADITIONAL) ATTN: BEN MA PHONE NO : 852 145 41883 BLOCK2, 5/F,. ROOM 8 SE DECISION MADE: 08-APR-02 NAN FUNG IND. CITY 510(k) SUMMARY AVAILABLE FROM FDA 18 TIN HAU ROAD, TUEN MUN N.T., HOTHIRD PARTY REVIEW DEVICE: MODEL GT010706 ELECTRONIC THERMOMETER GLOBAL TREASURE LTD. 510(k) NO: K021052(TRADITIONAL) ATTN: PHONE NO : BLOCK2, 5/F,. ROOM 8 SE DECISION MADE: 09-APR-02 NAN FUNG IND. CITY 510(k) SUMMARY AVAILABLE FROM FDA 18 TIN HAU ROAD, TUEN MUN N.T., HOTHIRD PARTY REVIEW DEVICE: GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LAB GREAT GLOVE SDN BHD 510(k) NO: K020363(TRADITIONAL) ATTN: NOOR AKILAH PHONE NO : 603 325 00646 24, JALAN RAJA MOKHTAR DUA SE DECISION MADE: 10-APR-02 KAPAR, SELANGOR D.E., MALAYSIA 422510(k) STATEMENT DEVICE: GYRUS ENT SOMNOPLASTY GENERATOR GYRUS ENT L.L.C. 510(k) NO: K020067(TRADITIONAL) ATTN: JEFFREY W COBB PHONE NO : 901-373-2673 2925 APPLING RD SE DECISION MADE: 04-APR-02 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERRALNYL H & A CONSULTANTS 510(k) NO: K020146(TRADITIONAL) ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414 2584 SADDLEWOOD LANE SE DECISION MADE: 15-APR-02 PALM HARBOR, FL 34685 510(k) STATEMENT DEVICE: SERRALSILK H & A CONSULTANTS 510(k) NO: K020901(TRADITIONAL) ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414 2584 SADDLEWOOD LANE SE DECISION MADE: 26-APR-02 PALM HARBOR, FL 34685 510(k) STATEMENT DEVICE: BIOSUC HAKKO MEDICAL CO., LTD. 510(k) NO: K013108(TRADITIONAL) ATTN: MSHIRO KITAGAWA PHONE NO : 81 3 4648500 7-9 KAMIMEGURO 1-CHOME SE DECISION MADE: 04-APR-02 MEGURO-KU, TOKYO, JAPAN 153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #L HAKKO SHOJI CO., LTD. 510(k) NO: K020307(TRADITIONAL) ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146 4545 CREEK ROAD SE DECISION MADE: 26-APR-02 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 HARVEST TECHNOLOGIES, CORP. 510(k) NO: K020252(TRADITIONAL) ATTN: JOHN D BONASERA PHONE NO : 508-732-7530 40 GRISSOM RD, SUITE 100 SE DECISION MADE: 05-APR-02 PLYMOUTH, MA 02360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSENSUS ACETABLAR SHELL, TI COATED HAYES MEDICAL, INC. 510(k) NO: K020153(TRADITIONAL) ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7156 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 15-APR-02 EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT DEVICE: HL168F HEALTH & LIFE CO., LTD. 510(k) NO: K020766(SPECIAL) ATTN: SUSAN CHEN PHONE NO : 886 232 349600 6F,NO. 407, CHUNG SHAN RD. SE DECISION MADE: 05-APR-02 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: HISONIC-TRD TINNITUS RELIEF DEVICE HEARING INNOVATIONS, INC. 510(k) NO: K013253(TRADITIONAL) ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5910 COLUMBIA SQUARE SE DECISION MADE: 05-APR-02 555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004-1109 DEVICE: HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 HEMOCUE, INC. 510(k) NO: K020935(SPECIAL) ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707 9229 CRANFORD DRIVE SE DECISION MADE: 03-APR-02 POTOMAC, MD 20854 510(k) STATEMENT DEVICE: HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER HOMMED LLC. 510(k) NO: K014025(TRADITIONAL) ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111 2018 NORTH DURHAM DRIVE SE DECISION MADE: 09-APR-02 HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOMMED CENTRAL STATION HOMMED LLC. 510(k) NO: K020184(TRADITIONAL) ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111 2018 NORTH DURHAM DRIVE SE DECISION MADE: 22-APR-02 HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16" HOSUK CO., LTD. 510(k) NO: K021197(SPECIAL) ATTN: CAROLE STAMP PHONE NO : 952-946-8080 5353 WAYZATA BLVD., STE 505 SE DECISION MADE: 26-APR-02 MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEKNIQUE-HOVEROUND POWER WHEEL CHAIR HOVEROUND CORP. 510(k) NO: K021136(SPECIAL) ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 19-APR-02 SARASOTA, FL 34243 510(k) STATEMENT DEVICE: 2 PIECE MODULAR HIP STEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K013106(TRADITIONAL) ATTN: WILLIAMR J CYMBALUK PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 03-APR-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONG LENGTH GAMMA NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K020773(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 04-APR-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVON PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. 510(k) NO: K020841(SPECIAL) ATTN: MARGARET F CROWE PHONE NO : 201-831-5580 59 ROUTE 17 SE DECISION MADE: 11-APR-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER EON PLUS FEMORAL STEMS HOWMEDICA OSTEONICS CORP. 510(k) NO: K020989(SPECIAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-831-5379 59 ROUTE 17 SE DECISION MADE: 26-APR-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K021026(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 25-APR-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S2 TIBIAL NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K021027(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 25-APR-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FETAL ASSIST HUNTLEIGH DIAGNOSTICS LTD. 510(k) NO: K020390(TRADITIONAL) ATTN: AUDREY WITKO PHONE NO : 800-223-1218 40 CHRISTOPHER WAY SE DECISION MADE: 19-APR-02 EATONTOWN, NJ 07724-3327 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR HYDROCISION, INC. 510(k) NO: K020688(SPECIAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 03-APR-02 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 53 HYGIA HEALTH SERVICES, INC. 510(k) NO: K012417(TRADITIONAL) ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670 2800 MILAN CT., SUITE 259 SE DECISION MADE: 08-APR-02 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP HYGIA HEALTH SERVICES, INC. 510(k) NO: K012650(TRADITIONAL) ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670 2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG HYGIA HEALTH SERVICES, INC. 510(k) NO: K012651(TRADITIONAL) ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670 2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE HYGIA HEALTH SERVICES, INC. 510(k) NO: K012654(TRADITIONAL) ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670 2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP HYGIA HEALTH SERVICES, INC. 510(k) NO: K012657(TRADITIONAL) ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670 2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB HYGIA HEALTH SERVICES, INC. 510(k) NO: K012956(TRADITIONAL) ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670 2800 MILAN CT., SUITE 259 SE DECISION MADE: 11-APR-02 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYALLERGYTEST SYSTEM IMMUNETECH CORPORATION 510(k) NO: K020387(TRADITIONAL) ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483 P.O. BOX 9433 SE DECISION MADE: 17-APR-02 17394 VIA DEL BRAVO 510(k) SUMMARY AVAILABLE FROM FDA RANCHO SANTA FE, CA 92067 DEVICE: BIOCELLECT -PERIO IMTEC CORP. 510(k) NO: K020396(TRADITIONAL) ATTN: M.K. PATTERSON PHONE NO : 405-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 10-APR-02 ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE CCP ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K020414(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 858-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 29-APR-02 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE-STEER GUIDE WIRE SYSTEM INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K011986(TRADITIONAL) ATTN: PAMELA L MISAJON PHONE NO : 760-918-1820 6354 CORTE DEL ABETO SE DECISION MADE: 03-APR-02 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: 4 ALL (DW286A) IVOCLAR VIVADENT, INC. 510(k) NO: K020253(TRADITIONAL) ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 17-APR-02 AMHERST, NY 14228 510(k) STATEMENT DEVICE: CHEMISTRY CALIBRATOR JAS DIAGNOSTIC, INC. 510(k) NO: K020454(TRADITIONAL) ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 08-APR-02 MIAMI, FL 33166 510(k) STATEMENT DEVICE: BOND-3 ADHESIVE JENERIC/PENTRON, INC. 510(k) NO: K020499(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-APR-02 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FOX PTA CATHETER JOMED AG 510(k) NO: K020854(SPECIAL) ATTN: CHRISTINA KICHULA PHONE NO : 301-998-6151 1700 ROCKVILLE PIKE, SUITE 400 SE DECISION MADE: 11-APR-02 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA JOSTRA AG 510(k) NO: K020515(TRADITIONAL) ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738 478 MEDIA ROAD SE DECISION MADE: 24-APR-02 OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K011793(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 17-APR-02 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XR PRIMER 2 KERR DENTAL MATERIALS CENTER 510(k) NO: K020303(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 19-APR-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L.A.M. IPM WOUND GEL L.A.M. PHARMACEUTICAL, CORP. 510(k) NO: K020325(TRADITIONAL) ATTN: CLAWSON BOWMAN PHONE NO : 707-793-2600 1330A REDWOOD WAY SE DECISION MADE: 15-APR-02 PETALUMA, CA 94954 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K020769(TRADITIONAL) ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360 2391 ZANKER RD., SUITE 340 SE DECISION MADE: 03-APR-02 SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESECTION ABLATOR LINVATEC CORP. 510(k) NO: K013369(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 04-APR-02 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS MACHNET BV 510(k) NO: K020289(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 24-APR-02 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTR MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K021155(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 29-APR-02 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: MID LABS AUTONOMOUS VIT ENHANCER (AVE) MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K020911(TRADITIONAL) ATTN: LINDA M UPTON PHONE NO : 510-357-3952 14477 CATALINA ST. SE DECISION MADE: 29-APR-02 SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K020147(TRADITIONAL) ATTN: LUCY TAN PHONE NO : 763-391-9000 7611 NORTHLAND DR. N SE DECISION MADE: 03-APR-02 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 MEDTRONIC, INC. 510(k) NO: K013517(TRADITIONAL) ATTN: KRISTY K MOLLNER PHONE NO : 763-514-4189 7000 CENTRAL AVE. N.E. SE DECISION MADE: 25-APR-02 MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K021077(TRADITIONAL) ATTN: RONDA K MAGNESON PHONE NO : 801-576-9669 11506 SOUTH STATE ST. SE DECISION MADE: 17-APR-02 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HDR MIAMI APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K020176(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 914-667-3999 521 HOMESTEAD AVE. SE DECISION MADE: 08-APR-02 MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRULINE REINFORCED VALVED INFUSION CATHETER MICRO THERAPEUTICS, INC. 510(k) NO: K021139(SPECIAL) ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 17-APR-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R MILLIPORE CORP. 510(k) NO: K013988(SPECIAL) ATTN: THOMAS BORROWS PHONE NO : 781-533-2622 80 ASHBY RD. SE DECISION MADE: 04-APR-02 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: FUSION 7D MIRADA SOLUTIONS LTD 510(k) NO: K020546(TRADITIONAL) ATTN: ROGER W BARNES PHONE NO : 501-525-8612 342 SUNSET BAY ROAD SE DECISION MADE: 26-APR-02 HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALIBRATING MATERIAL, CAL-PAK, BUFFERS MISSION DIAGNOSTICS 510(k) NO: K020894(TRADITIONAL) ATTN: LINDA STUNDTNER PHONE NO : 508-429-0450 331 FISKE ST. SE DECISION MADE: 29-APR-02 HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 MONOBIND 510(k) NO: K020548(TRADITIONAL) ATTN: JAY SINGH PHONE NO : 949-642-4830 729 WEST 16TH ST., C-4 SE DECISION MADE: 05-APR-02 COSTA MESA, CA 92627 510(k) STATEMENT DEVICE: SURGIC IV IMPLANT CONTROL UNIT NAKANISHI, INC. 510(k) NO: K020327(TRADITIONAL) ATTN: HIROJI SEKIGUCHI PHONE NO : 011 812 89643422 700 SHIMOHINATA SE DECISION MADE: 08-APR-02 KANUMA-SHI, TOCHIGI-KEN, JAPAN 322510(k) STATEMENT DEVICE: WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 NELLCOR PURITAN BENNETT, INC. 510(k) NO: K020604(SPECIAL) ATTN: GINA TO PHONE NO : 925-463-4427 4280 HACIENDA DR. SE DECISION MADE: 23-APR-02 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT-C3000 SPIRAL CT SCANNER SYSTEM NEUSOFT DIGITAL MEDICAL SYSTEM CO.510(k) NO: K020913(TRADITIONAL) ATTN: WANG ZHIQIANG PHONE NO : 86 24 23783000 NO.3-11, WENHUA ROAD SE DECISION MADE: 03-APR-02 HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW DEVICE: SNAP EEG MONITOR NICOLET BIOMEDICAL, INC. 510(k) NO: K020218(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 22-APR-02 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICOLET ELECTROCAUTERY DETECTOR NICOLET BIOMEDICAL, INC. 510(k) NO: K020955(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 17-APR-02 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSALAB APM NICOLET VASCULAR, INC. 510(k) NO: K013281(ABBREVIATED) ATTN: DAVID W WAGNER PHONE NO : 303-431-9400 6355 JOYCE DR. SE DECISION MADE: 18-APR-02 GOLDEN, CO 80403 510(k) STATEMENT DEVICE: NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 NIDEK, INC. 510(k) NO: K014274(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 17-APR-02 LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE THERAPY SYSTEM NXSTAGE MEDICAL, INC. 510(k) NO: K020858(SPECIAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION STREET SE DECISION MADE: 17-APR-02 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843 DEVICE: OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K020690(TRADITIONAL) ATTN: CHARLES R VERMETTE PHONE NO : 510-724-0384 629 TENNENT AVE. SE DECISION MADE: 26-APR-02 PINOLE, CA 94564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K020601(TRADITIONAL) ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010 P.O. BOX 248 SE DECISION MADE: 24-APR-02 YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS OHIO MEDICAL INSTRUMENT CO., INC. 510(k) NO: K013428(TRADITIONAL) ATTN: DONALD A LINCOLN PHONE NO : 508-384-2506 10 OAK POINT SE DECISION MADE: 04-APR-02 WRENTHAM, MA 02093 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I ORASURE TECHNOLOGIES, INC. 510(k) NO: K013882(TRADITIONAL) ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820 1745 EATON AVE SE DECISION MADE: 17-APR-02 BETHLEHEM, PA 18018-1799 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UPLINK TEST SYSTEM ORASURE TECHNOLOGIES, INC. 510(k) NO: K020371(TRADITIONAL) ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820 1745 EATON AVE SE DECISION MADE: 03-APR-02 BETHLEHEM, PA 18018-1799 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVISION ANTERIOR CERVICAL PLATE SYSTEM ORTHO DEVELOPMENT CORP. 510(k) NO: K020649(TRADITIONAL) ATTN: CAROL FREASIER PHONE NO : 801-553-9991 12187 S. BUSINESS PARK DR. SE DECISION MADE: 05-APR-02 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAG ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K020662(TRADITIONAL) ATTN: ANN M QUINN PHONE NO : 716-453-4041 100 INDIGO CREEK DRIVE SE DECISION MADE: 12-APR-02 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM ORTHOPAEDIC INNOVATIONS, INC. 510(k) NO: K020145(TRADITIONAL) ATTN: GREGORY M MERCURI PHONE NO : 763-591-0001 6188 OLSON MEMORIAL HWY. SE DECISION MADE: 15-APR-02 GOLDEN VALLEY, MN 55422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXOID PBP2 1 LATEX AGGLUTINATION TEST OXOID, LTD. 510(k) NO: K011710(TRADITIONAL) ATTN: A. HOLLINGSWORTH PHONE NO : 012 568 41144 WADE RD. SE DECISION MADE: 02-APR-02 BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT DEVICE: DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS) PACIFIC CONSOLIDATED INDUSTRIES LL510(k) NO: K020330(ABBREVIATED) ATTN: LEE W SMITH PHONE NO : 714-979-9200 3430 WEST CARRIAGE DRIVE SE DECISION MADE: 12-APR-02 SANTA ANA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVS BASIC 2; EPIC 2 PARAGON VISION SCIENCES 510(k) NO: K013310(TRADITIONAL) ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606 947 EAST IMPALA AVE. SE DECISION MADE: 25-APR-02 MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATTON TRIPOL PATTON MEDICAL CORP. 510(k) NO: K012279(TRADITIONAL) ATTN: MICHAEL T PATTON PHONE NO : 512-329-0469 1000 WESTBANK DRIVE SE DECISION MADE: 30-APR-02 SUITE 5A200 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78746 DEVICE: SONATA MICRO HYBRID COMPOSITE PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K020555(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-APR-02 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K020708(ABBREVIATED) ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319 3000 MINUTEMAN RD. SE DECISION MADE: 25-APR-02 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 50S TRINGA ULTRASOUND IMAGING SYSTEM PIE MEDICAL 510(k) NO: K020112(TRADITIONAL) ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916 8000 CASTLEWAY DRIVE SE DECISION MADE: 19-APR-02 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALE LATEX CONDOM WITH RIBBED SURFACE PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K020272(ABBREVIATED) ATTN: KOI-YONG LIM PHONE NO : 603 326 40784 LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 26-APR-02 SUNGAI SEMBILANG 510(k) STATEMENT JERAM, SELANGOR DARUL EHSAN, MALAYSIA 45800 DEVICE: POLYMEDCO HBA1C TEST POLYMEDCO, INC. 510(k) NO: K020532(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 425-814-1514 510 FURNACE DOCK RD. SE DECISION MADE: 24-APR-02 CORTLANDT MANOR, NY 10567 510(k) STATEMENT DEVICE: VT-1 POS-T-VAC, INC. 510(k) NO: K020154(TRADITIONAL) ATTN: DENNIS L BELL PHONE NO : 800-279-7434 1701 NORTH 14TH AVE. SE DECISION MADE: 04-APR-02 DODGE CITY, KS 67801 510(k) STATEMENT DEVICE: SUPPORT SLEEVE POS-T-VAC, INC. 510(k) NO: K020258(TRADITIONAL) ATTN: DENNIS L BELL PHONE NO : 800-279-7434 1701 NORTH 14TH AVE. SE DECISION MADE: 04-APR-02 DODGE CITY, KS 67801 510(k) STATEMENT DEVICE: SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED RE POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K020343(SPECIAL) ATTN: LAURENCE A POTTER PHONE NO : 215-862-4450 110 UNION SQUARE DR. SE DECISION MADE: 10-APR-02 NEW HOPE, PA 18938-1364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAG PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K021076(SPECIAL) ATTN: BRENDA LEE PHONE NO : 780 497 7600 X225 10707-100TH AVE., SUITE 300 SE DECISION MADE: 16-APR-02 EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) STATEMENT DEVICE: MITYVAC MERLIN, MODEL 10027 PRISM ENTERPRISES, INC. 510(k) NO: K020447(SPECIAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET N.W. SE DECISION MADE: 12-APR-02 WASHINGTON, DC 20004-5600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS PRO-TECH SERVICES, INC. 510(k) NO: K013905(SPECIAL) ATTN: NEIL SHELLER PHONE NO : 425-481-5452 4338 HARBOUR POINTE BLVD. S.W. SE DECISION MADE: 22-APR-02 MUKILTEO, WA 98275 510(k) STATEMENT DEVICE: DENTITION INTEGRATING MATERIAL PULPDENT CORPORATION 510(k) NO: K020287(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND STREET SE DECISION MADE: 12-APR-02 WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT GLAZE PULPDENT CORPORATION 510(k) NO: K020432(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND STREET SE DECISION MADE: 17-APR-02 WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT POST CEMENT PULPDENT CORPORATION 510(k) NO: K020481(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND STREET SE DECISION MADE: 17-APR-02 WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RE-USABLE STERILIZATION POUCH / BAG QUALITY PRODUCTS OF MONTANA 510(k) NO: K013715(TRADITIONAL) ATTN: LARRY LARSON PHONE NO : 406-542-0950 100 NORTH JOHNSON #7 SE DECISION MADE: 01-APR-02 MISSOULA, MT 59801 510(k) STATEMENT DEVICE: VIRIDIS DERMA LASER QUANTEL MEDICAL 510(k) NO: K020071(TRADITIONAL) ATTN: ROGER W BARNES PHONE NO : 501-525-8612 342 SUNSET BAY ROAD SE DECISION MADE: 05-APR-02 HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHOS LASER QUANTEL MEDICAL 510(k) NO: K020072(TRADITIONAL) ATTN: ROGER W BARNES PHONE NO : 501-525-8612 342 SUNSET BAY ROAD SE DECISION MADE: 09-APR-02 HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RPI SKIN OR AIR TEMPERATURE PROBE REPLACEMENT PARTS INDUSTRIES, INC.510(k) NO: K020219(TRADITIONAL) ATTN: IRA LAPIDES PHONE NO : 818-882-8611 P.O. BOX 5019 SE DECISION MADE: 12-APR-02 CHATSWORTH, CA 91313-5019 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L RHIGENE, INC. 510(k) NO: K011068(TRADITIONAL) ATTN: DAVID KOLESAR PHONE NO : 847-375-9091 455 STATE ST., SE DECISION MADE: 11-APR-02 SUITE 104 510(k) STATEMENT DES PLAINES, IL 60068 DEVICE: CLEARVIEW WRIST FIXATOR RIGID FX ORTHOPEDICS, INCORPORATED510(k) NO: K020311(TRADITIONAL) ATTN: MARK ESTRADA PHONE NO : 512-443-7770 3601 S. CONGRESS, BLDG B #300 SE DECISION MADE: 29-APR-02 AUSTIN, TX 78704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ONLINE THEOPHYLLINE ROCHE DIAGNOSTICS CORP. 510(k) NO: K020740(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 16-APR-02 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NETLINK/NETSCAN ROZINN ELECTRONICS, INC. 510(k) NO: K020213(TRADITIONAL) ATTN: MARK ROSOFF PHONE NO : 718-386-5526 71-22 MYRTLE AVE. SE DECISION MADE: 05-APR-02 GLENDALE, NY 11385 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUBICOR BREAST BIOPSY DEVICE RUBICOR MEDICAL, INC. 510(k) NO: K020047(TRADITIONAL) ATTN: ROBERT J CHIN PHONE NO : 650-593-5225 25 HARTFORD AVENUE SE DECISION MADE: 05-APR-02 SAN CAROLS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM SCANDIA MANUFACTURING LTD. 510(k) NO: K003916(TRADITIONAL) ATTN: RONALD E BERGLUND PHONE NO : 612-888-8282 9220 JAMES AVENUE SOUTH SE DECISION MADE: 15-APR-02 BLOOMINGTON, MN 55431 510(k) STATEMENT DEVICE: MONITORING SYSTEM,MODEL ARGUS PB-1000 SCHILLER AG 510(k) NO: K012226(TRADITIONAL) ATTN: MARKUS BUETLER PHONE NO : 041 766 4252 ALTGASSE 68 SE DECISION MADE: 08-APR-02 BAAR, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WH SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K020868(TRADITIONAL) ATTN: CHUN CHOOI FONG PHONE NO : 605 322 3200 LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 22-APR-02 PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA LAHAT, IPOH, PERAK, MALAYSIA 31500 DEVICE: MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS SMITH & NEPHEW, INC. 510(k) NO: K020947(SPECIAL) ATTN: DEBORAH CONNERS PHONE NO : 978-749-1495 160 DASCOMB RD. SE DECISION MADE: 17-APR-02 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER SPIRE BIOMEDICAL INC 510(k) NO: K013160(TRADITIONAL) ATTN: DONALD FICKETT PHONE NO : 781-275-6000 ONE PATRIOTS PARK SE DECISION MADE: 11-APR-02 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPR SSL AMERICA'S, INC. 510(k) NO: K020308(TRADITIONAL) ATTN: JOYCE NING PHONE NO : 770-582-2152 3585 ENGINEERING DR.,SUITE 200 SE DECISION MADE: 03-APR-02 P.O. BOX 926090 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092-9214 DEVICE: SPYGLASS 4 FR ANGIOGRAPHICY CATHETER ST. JUDE MEDICAL 510(k) NO: K020890(SPECIAL) ATTN: KIRK S HONOUR PHONE NO : 952-352-9737 14901 DEVEAU PL. SE DECISION MADE: 17-APR-02 MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED GUIDEWIRES STERILMED, INC. 510(k) NO: K012556(TRADITIONAL) ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH SE DECISION MADE: 29-APR-02 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY SIMPLEX SOFT INFUSION SET STERLING MEDIVATIONS, INC. 510(k) NO: K020629(ABBREVIATED) ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470 25285 LA LOMA DR. SE DECISION MADE: 01-APR-02 LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT DEVICE: SIMPLICITY EASY SOFT INFUSION SET STERLING MEDIVATIONS, INC. 510(k) NO: K020912(ABBREVIATED) ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470 25285 LA LOMA DR. SE DECISION MADE: 10-APR-02 LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION STERLING MEDIVATIONS, INC. 510(k) NO: K020990(SPECIAL) ATTN: JOEL DOUGLAS PHONE NO : 408-297-9474 25285 LA LOMA DR. SE DECISION MADE: 10-APR-02 LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT DEVICE: SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJEC STERLING MEDIVATIONS, INC. 510(k) NO: K021005(ABBREVIATED) ATTN: JOEL DOUGLAS PHONE NO : 650-814-4083 25285 LA LOMA DR. SE DECISION MADE: 25-APR-02 LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT DEVICE: APOLLO, MODEL 1124525 STERNGOLD 510(k) NO: K020949(ABBREVIATED) ATTN: MARIA RAO PHONE NO : 508-226-5660 23 FRANK MOSSBERG DR. SE DECISION MADE: 04-APR-02 ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM STETHOGRAPHICS, INC. 510(k) NO: K012387(TRADITIONAL) ATTN: HARVEY KNAUSS PHONE NO : 713-723-4080 11874 S. EVELYN CIRCLE SE DECISION MADE: 23-APR-02 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAL-CHEX CD PLUS STRECK LABORATORIES, INC. 510(k) NO: K020469(TRADITIONAL) ATTN: PAUL KITTELSON PHONE NO : 402-537-5312 7002 SOUTH 109TH ST. SE DECISION MADE: 04-APR-02 LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANNULOFLO SYSTEM, MITRAL MODEL AR700 SULZER CARBOMEDICS, INC. 510(k) NO: K021051(SPECIAL) ATTN: TEFFANY HANKINSON PHONE NO : 512-435-3202 1300 EAST ANDERSON LN. SE DECISION MADE: 23-APR-02 AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRASTENT LD (LARGE DIAMETER) STENT SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K020528(SPECIAL) ATTN: GLEN D SMYTHE PHONE NO : 651-697-4815 651 CAMPUS DR. SE DECISION MADE: 16-APR-02 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K014089(TRADITIONAL) ATTN: MING SUN PHONE NO : 856-401-1080 604 VPR CENTER SE DECISION MADE: 25-APR-02 1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA BLACKWOOD, NJ 08012 DEVICE: INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERN SURGI-VISION, INC. 510(k) NO: K020495(TRADITIONAL) ATTN: NANCY E TAYLOR PHONE NO : 301-527-2000 20 FIRSTFIELD RD. SUITE 200 SE DECISION MADE: 23-APR-02 GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X SUTURA, INC. 510(k) NO: K020940(SPECIAL) ATTN: JAMES BONDS PHONE NO : 714-437-9801 17080 NEWHOPE ST. SE DECISION MADE: 17-APR-02 FOUNTAIN VALLEY, CA 92708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) SYNTERMED, INC. 510(k) NO: K020300(TRADITIONAL) ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256 245 OWENS DRIVE SE DECISION MADE: 23-APR-02 ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES VERTEBRAL SPACER TI SYNTHES (USA) 510(k) NO: K020152(TRADITIONAL) ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 16-APR-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES TRANSLATING MAXILLARY DISTRACTOR SYNTHES (USA) 510(k) NO: K020505(TRADITIONAL) ATTN: MATTHEW H HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 23-APR-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES DUAL-OPENING USS SYNTHES (USA) 510(k) NO: K020517(SPECIAL) ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 15-APR-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) SYNTHES SPINE 510(k) NO: K020244(TRADITIONAL) ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700 1380 ENTERPRISE DRIVE SE DECISION MADE: 22-APR-02 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL SYSMEX CORPORATION OF AMERICA 510(k) NO: K020496(TRADITIONAL) ATTN: NINA GAMPERLING PHONE NO : 847-726-3675 6699 WILDLIFE WAY SE DECISION MADE: 12-APR-02 LONG GROVE, IL 60047-9596 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIIS#1 TISSUE SUSPENSION SYSTEM TAG MEDICAL PRODUCTS 510(k) NO: K020705(TRADITIONAL) ATTN: DAN MOOR PHONE NO : 011 972 49858400 SE DECISION MADE: 26-APR-02 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM TECHNOLOGY DELIVERY SYSTEMS, INC. 510(k) NO: K013300(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE, STE C-100 SE DECISION MADE: 16-APR-02 PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSUEMEND SOFT TISSUE REPAIR MATRIX TEI BIOSCIENCES INC. 510(k) NO: K020455(ABBREVIATED) ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS STREET SE DECISION MADE: 03-APR-02 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K020998(SPECIAL) ATTN: GARRY COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 04-APR-02 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAHURKAR TRIPLE LUMEN CATHETER, 12 FR THE KENDALL COMPANY 510(k) NO: K020089(TRADITIONAL) ATTN: REGINA YEH PHONE NO : 508-261-8404 15 HAMPSHIRE ST. SE DECISION MADE: 10-APR-02 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AL-2000 COMBINED BIOMETER AND PACHYMETER TOMEY CORP. 510(k) NO: K012803(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 08-APR-02 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UD-1000 ULTRASONIC A/B SCANNER TOMEY CORP. USA 510(k) NO: K020151(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 10-APR-02 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSPOINT TRANSACCESS CATHETER TRANS VASCULAR INCORPORATED 510(k) NO: K013363(TRADITIONAL) ATTN: STEVE JWANOUSKOS PHONE NO : 650-473-4500 1505-D ADAMS DRIVE SE DECISION MADE: 02-APR-02 MENLO PARK, CA 94925 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 U-SYSTEMS, INC. 510(k) NO: K013848(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114 2081 LONGDEN CIRCLE SE DECISION MADE: 08-APR-02 LOS ALTOS,, CA 94204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRAL RADIUS 90-D RODDING SYSTEM UNITED STATES SURGICAL, A DIVISION510(k) NO: K020134(TRADITIONAL) ATTN: JENNIFER SCHUCK PHONE NO : 203-845-4512 150 GLOVER AVE. SE DECISION MADE: 15-APR-02 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAV COMBI-2 VIBRANT HEALTH 510(k) NO: K020565(TRADITIONAL) ATTN: STEPHEN EMOND PHONE NO : 450 526 1295 150 DES GRANDS COTEAUX SE DECISION MADE: 30-APR-02 BEOEIL, QUEBEC, CANADA J3G 2C9 510(k) STATEMENT DEVICE: AKUPORT M-2 VIBRANT HEALTH 510(k) NO: K020568(TRADITIONAL) ATTN: STEPHEN EMOND PHONE NO : 450 526 1295 150 DES GRANDS COTEAUX SE DECISION MADE: 30-APR-02 BEOEIL, QUEBEC, CANADA J3G 2C9 510(k) STATEMENT DEVICE: EAV KINDLING 2000S GSR DEVICE VIRBRANT HEALTH 510(k) NO: K020564(TRADITIONAL) ATTN: STEPHEN EMOND PHONE NO : 450 526 1295 150 DES GRANDS COTEAUX SE DECISION MADE: 30-APR-02 BELOEIL, QUEBEC, CANADA J3G 2C9 510(k) STATEMENT DEVICE: LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE VIVOMETRICS, INC. 510(k) NO: K011903(TRADITIONAL) ATTN: KEITH GILROY PHONE NO : 805-667-2225 121 NORTH FIR STREET SE DECISION MADE: 12-APR-02 SUITE E 510(k) SUMMARY AVAILABLE FROM FDA VENTURA, CA 93001 DEVICE: DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 WELL-LIFE HEALTHCARE, INC. 510(k) NO: K020314(TRADITIONAL) ATTN: TONY C.S. CHANG PHONE NO : 886 422 972787 NO. 5 ALLEY 5 LANE CHENG HSING SE DECISION MADE: 30-APR-02 CHUNG CHING RD., PEI TUN DIST. 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) DEVICE: DIGI-PRO TENS MODEL WL-2203 AND WL-2205 WELL-LIFE HEALTHCARE, INC. 510(k) NO: K021359(TRADITIONAL) ATTN: TONY C.S. CHANG PHONE NO : 886 422 972476 NO. 5 ALLEY 5 LANE CHENG HSING SE DECISION MADE: 30-APR-02 CHUNG CHING RD., PEI TUN DIST. 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) DEVICE: AGC SPEZIALLEGIERUNG WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K020347(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 49 723 13705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 24-APR-02 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI HI-FLO PNEU, WISAP #7080 WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K011510(TRADITIONAL) ATTN: HORST SEMM PHONE NO : 490 810 489080 RUDOLF-DIESEL-RING 20 SE DECISION MADE: 02-APR-02 SAUERLACH, GERMANY D-82054 510(k) STATEMENT DEVICE: THERMOMETER MODELS ST8631 Z7 INTERNATIONAL 510(k) NO: K021048(TRADITIONAL) ATTN: PHIL ZULUETA PHONE NO : 661-269-1006 34138 COURTNEY TERRACE SE DECISION MADE: 22-APR-02 ACTON, CA 93510 510(k) STATEMENT DEVICE: MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYS ZEUS SCIENTIFIC, INC. 510(k) NO: K021103(SPECIAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 P.O. BOX 38 SE DECISION MADE: 24-APR-02 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: ZOLL PAD WITH CPR AID ZOLL MEDICAL CORP. 510(k) NO: K011541(TRADITIONAL) ATTN: PAUL DIAS PHONE NO : 800-242-9150 32 SECOND AVENUE SE DECISION MADE: 11-APR-02 BURLINGTON, MA 01803-4420 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 274 TOTAL WITH SUMMARIES 222 TOTAL WITH STATEMENTS 52
Updated 4/28/2004
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