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510(k)s Final Decisions Rendered for April 2003 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-APR-2003 THROUGH 30-APR-2003 DEVICE: AAP ACROPLATE AAP IMPLANTATE AG 510(k) NO: K030909(TRADITIONAL) ATTN: DIPL.-LNG. CHRISTIAN ABEL PHONE NO : 49 30 75019190 LORENZWEG 5 SE DECISION MADE: 10-APR-03 BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM ABBOTT LABORATORIES 510(k) NO: K023256(TRADITIONAL) ATTN: JANET CONNOLLY PHONE NO : 781-276-6230 4-A CROSBY DR. SE DECISION MADE: 23-APR-03 BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE ABBOTT LABORATORIES 510(k) NO: K031185(TRADITIONAL) ATTN: PATRICIA MELERSKI PHONE NO : 847-938-3718 D-389, BLDG. J45-2 SE DECISION MADE: 30-APR-03 200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA ABBOTT PARK, IL 60064-6157 THIRD PARTY REVIEW DEVICE: MICROS 60 ABX DIAGNOSTICS 510(k) NO: K030799(SPECIAL) ATTN: TIM LAWTON PHONE NO : 334 671 47320 PARC EUROMEDECINE SE DECISION MADE: 08-APR-03 BP-7290 RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA MONTPELLIER CEDEX, FRANCE 4 34184 DEVICE: BATTERY, RECHARGEABLE ACCESS BATTERY, INC. 510(k) NO: K030261(TRADITIONAL) ATTN: ALEXANDER B HENDERSON PHONE NO : 800-373-3301 5357 HIGHWAY 86 SE DECISION MADE: 24-APR-03 ELIZABETH, CO 80107 510(k) STATEMENT DEVICE: ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DE ACON LABORATORIES, INC. 510(k) NO: K024350(TRADITIONAL) ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 02-APR-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MID STREAM PREGNANCY TEST ADVANCED DIAGNOSTICS, INC. 510(k) NO: K023037(TRADITIONAL) ATTN: D.M. CHOUHAN PHONE NO : 908-254-4880 801 MONTROSE AVE. SE DECISION MADE: 09-APR-03 SO. PLAINFIELD, NJ 07080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K030092(TRADITIONAL) ATTN: PAUL J NOWACKI PHONE NO : 714-247-8601 1700 E. ST. ANDREW PLACE SE DECISION MADE: 04-APR-03 P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA SANTA ANA, CA 92799-5162 DEVICE: A127 LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K030461(TRADITIONAL) ATTN: RASHMI MOZA PHONE NO : 972-309-8000 6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 24-APR-03 PLANO, TX 75024 510(k) STATEMENT DEVICE: STERRAD 50 & STERRAD 100S STERILIZERS ADVANCED STERILIZATION PRODUCTS 510(k) NO: K023290(TRADITIONAL) ATTN: NATALIE BENNINGTON PHONE NO : 949-453-6482 33 TECHNOLOGY DR. SE DECISION MADE: 03-APR-03 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEELEX ELECTRODE SET AESCULAP, INC. 510(k) NO: K030556(TRADITIONAL) ATTN: GEORG KELLER PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 22-APR-03 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A/T X-RAY 70 AIR TECHNIQUES, INC. 510(k) NO: K024285(TRADITIONAL) ATTN: JOSEPH CAREY PHONE NO : 516-433-7676 70 CANTIAGUE ROCK RD. SE DECISION MADE: 16-APR-03 HICKSVILLE, NY 11801 510(k) STATEMENT DEVICE: MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K030459(TRADITIONAL) ATTN: RENEE L FLUET PHONE NO : 858-458-7563 10221 WATERIDGE CIR. SE DECISION MADE: 04-APR-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLY STAT SERUM/URINE HCG TEST ALIDEX, INC. 510(k) NO: K030430(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 425-814-1514 12277 134TH CT., N.E., #100 SE DECISION MADE: 18-APR-03 REDMOND, WA 98052 510(k) STATEMENT DEVICE: AXCEL SURGICAL LIGHT ALM 510(k) NO: K030906(SPECIAL) ATTN: FREDERICK R CATT PHONE NO : 585-272-5013 1777 EAST HENRIETTA ROAD SE DECISION MADE: 23-APR-03 ROCHESTER, NY 14623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 'RAPIDTEC'-5M-MULTIPLE DIP TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K023869(TRADITIONAL) ATTN: HENRY WELLS PHONE NO : 410-992-4734 9110 RED BRANCH ROAD SE DECISION MADE: 30-APR-03 COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIOLASE 980 D LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC.510(k) NO: K023547(TRADITIONAL) ATTN: MARCIA VAN VALEN PHONE NO : 949-425-1417 12 PRAIRIE FALCON SE DECISION MADE: 15-APR-03 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE RO+ MODEL MROS09 AMERIWATER 510(k) NO: K030059(TRADITIONAL) ATTN: BRIAN R BOWMAN PHONE NO : 937-461-8833 1257 STANLEY AVE. SE DECISION MADE: 07-APR-03 DAYTON, OH 45404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-125 RAPID STRAND, MODEL 7000 AMERSHAM HEALTH 510(k) NO: K030594(SPECIAL) ATTN: SUBHASH PATEL PHONE NO : 609-514-6846 101 CARNEGIE CENTER SE DECISION MADE: 10-APR-03 PRINCETON, NJ 08540-6231 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K030415(TRADITIONAL) ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 30-APR-03 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: PANCREATIC DRAINAGE TUBE AOMORI OLYMPUS CO., LTD. 510(k) NO: K021672(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 2 CORPORATE CENTER DRIVE SE DECISION MADE: 16-APR-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K030245(TRADITIONAL) ATTN: LINGA SUMARTA PHONE NO : 62 216 620201/195 128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 04-APR-03 MANSYUR 510(k) STATEMENT JAKARTA BARAT, INDONESIA 11210 DEVICE: STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, ARROW INTERNATIONAL, INC. 510(k) NO: K030937(SPECIAL) ATTN: BRANDON EPTING PHONE NO : 610-378-0131 2400 BERNVILLE ROAD SE DECISION MADE: 23-APR-03 READING, PA 19605-9607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE PERCD SPINEWAND ARTHROCARE CORP. 510(k) NO: K030954(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 16-APR-03 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA PELVIC MUSCLE TRAINER ATHENA FEMININE TECHNOLOGIES, INC.510(k) NO: K023905(TRADITIONAL) ATTN: BARBARA SARKIS PHONE NO : 925-254-6090 179 MORAGA WAY SE DECISION MADE: 30-APR-03 ORINDA, CA 92520 510(k) STATEMENT DEVICE: AVANTA CARPAL FUSION PLATING SYSTEM AVANTA ORTHOPAEDICS, INC. 510(k) NO: K030881(TRADITIONAL) ATTN: H. DOUG PLUNKETT PHONE NO : 763-783-5017 8600 EVERGREEN BLVD SE DECISION MADE: 10-APR-03 MINNEAPOLIS, MN 55433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135, AVANTEC VASCULAR CORP. 510(k) NO: K030062(TRADITIONAL) ATTN: JAMES M SHY PHONE NO : 408-743-3100 1049 KIEL CT. SE DECISION MADE: 03-APR-03 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 BAXTER HEALTHCARE CORP. 510(k) NO: K030974(SPECIAL) ATTN: DAVID E CURTIN PHONE NO : 847-473-6079 1620 WAUKEGAN RD., MPR-D1 SE DECISION MADE: 25-APR-03 MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 BAXTER HEALTHCARE CORP. 510(k) NO: K030975(SPECIAL) ATTN: DAVID E CURTIN PHONE NO : 847-473-6079 1620 WAUKEGAN RD., MPR-D1 SE DECISION MADE: 25-APR-03 MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL BAYER HEALTHCARE, LLC 510(k) NO: K030801(ABBREVIATED) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 09-APR-03 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR BAYER HEALTHCARE, LLC 510(k) NO: K030804(ABBREVIATED) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 10-APR-03 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER ACT 5DIFF AUTOLOADER (AL) BECKMAN COULTER, INC. 510(k) NO: K030291(ABBREVIATED) ATTN: LOURDES COBA PHONE NO : 305-380-4079 11800 SW 147TH AVENUE SE DECISION MADE: 17-APR-03 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER LH 750 BODY FLUIDS APPLICATION BECKMAN COULTER, INC. 510(k) NO: K030606(ABBREVIATED) ATTN: STAN SUGRUE PHONE NO : 305-380-4552 11800 SW 147TH AVENUE SE DECISION MADE: 21-APR-03 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS OPIATE REAGENT BECKMAN COULTER, INC. 510(k) NO: K031002(SPECIAL) ATTN: KIM WALKER PHONE NO : 714-961-4912 200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 29-APR-03 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIV BECTON, DICKINSON AND COMPANY 510(k) NO: K030677(TRADITIONAL) ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 01-APR-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM BIO-LOGIC SYSTEMS CORP. 510(k) NO: K031009(SPECIAL) ATTN: NORMAN E BRUNNER PHONE NO : 800-323-8326 ONE BIO-LOGIC PLAZA SE DECISION MADE: 28-APR-03 MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A BIOMET, INC. 510(k) NO: K030555(TRADITIONAL) ATTN: LONNIE WITHAM PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 11-APR-03 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSABOARD, MODEL 7040 BIONIX DEVELOPMENT CORP. 510(k) NO: K030051(TRADITIONAL) ATTN: JAMES HUTTNER PHONE NO : 419-727-8421 5154 ENTERPRISE BLVD. SE DECISION MADE: 04-APR-03 TOLEDO, OH 43612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPACT SUTURE ANCHOR. MODEL 433510 BIONX IMPLANTS, LTD. 510(k) NO: K030388(TRADITIONAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 HERMIANKATU 6-8 L SE DECISION MADE: 24-APR-03 TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFAC BIOPLATE, INC. 510(k) NO: K030806(SPECIAL) ATTN: CAROL E JONES PHONE NO : 310-815-2100 3643 LENAWEE AVE. SE DECISION MADE: 08-APR-03 LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILL BIOPLATE, INC. 510(k) NO: K031028(SPECIAL) ATTN: CAROL E JONES PHONE NO : 310-815-2100 3643 LENAWEE AVE. SE DECISION MADE: 28-APR-03 LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP BIOTRONIK, INC. 510(k) NO: K023205(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 24-APR-03 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCULPTING RESIN BISCO, INC. 510(k) NO: K030585(TRADITIONAL) ATTN: STEPHEN SMITH PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 28-APR-03 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K030595(TRADITIONAL) ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711 90 BROOKSDALE DR. SE DECISION MADE: 24-APR-03 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR BLACKSTONE MEDICAL, INC. 510(k) NO: K030862(SPECIAL) ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711 90 BROOKSDALE DR. SE DECISION MADE: 17-APR-03 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ K BOSTON SCIENTIFIC CORP. 510(k) NO: K030855(SPECIAL) ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 17-APR-03 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBRA BIPOLAR CLAMP, MODEL 15902 BOSTON SCIENTIFIC EP TECHNOLOGIES 510(k) NO: K023288(TRADITIONAL) ATTN: APRIL MALMBORG PHONE NO : 408-895-3637 2710 ORCHARD PARKWAY SE DECISION MADE: 02-APR-03 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL HIGH SPEED MOTOR DRILL SYSTEM BRASSELER USA I, L.P. 510(k) NO: K030172(TRADITIONAL) ATTN: ANTHONY V ROSE PHONE NO : 805-650-5209 4837 MCGRATH STREET, SUITE J SE DECISION MADE: 03-APR-03 VENTURA, CA 93003 510(k) STATEMENT DEVICE: 2 BASIC CAPINTEC, INC. 510(k) NO: K030175(TRADITIONAL) ATTN: MARY ANNE DELL PHONE NO : 412-963-1988 540 ALPHA DR. SE DECISION MADE: 17-APR-03 PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K030451(TRADITIONAL) ATTN: ROBERT W JOHNSON PHONE NO : 651-653-8512 1290 HAMMOND RD. SE DECISION MADE: 30-APR-03 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLONCARE CARE PRODUCTS, INC. 510(k) NO: K030216(TRADITIONAL) ATTN: HUBERT POTOTSCHNIG PHONE NO : 203-753-0602 231 BANK STREET SE DECISION MADE: 02-APR-03 WATERBURY, CT 06702 510(k) STATEMENT DEVICE: CARE STIM CARE REHAB AND ORTHOPAEDIC 510(k) NO: K022417(TRADITIONAL) ATTN: CHRISTIAN E HUNT PHONE NO : 703-448-9644 1124 DOMINION CT. SE DECISION MADE: 10-APR-03 MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM CASE MEDICAL, INC. 510(k) NO: K023614(TRADITIONAL) ATTN: MARCIA A FRIEZE PHONE NO : 201-313-1999 65 RAILROAD AVE. SE DECISION MADE: 07-APR-03 RIDGEFIELD, NJ 07657-0402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, A CENOGENICS CORP. 510(k) NO: K030533(TRADITIONAL) ATTN: NITZ KATZ PHONE NO : 732-536-6457 100 RT. 520 SE DECISION MADE: 17-APR-03 MORGANVILLE, NJ 07751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMATOMICAL SHOULDER WITH REMOVABLE HEAD CENTERPLUS ORTHOPEDICS, INC 510(k) NO: K030259(TRADITIONAL) ATTN: AUDREY SWEARINGEN PHONE NO : 512-432-9255 9900 SPECTRUM DR. SE DECISION MADE: 24-APR-03 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY CLEARLAB PTE LTD. 510(k) NO: K030167(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 02-APR-03 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS CODONICS, INC. 510(k) NO: K030690(TRADITIONAL) ATTN: RICK DAYTON PHONE NO : 440-243-1198 17991 ENGLEWOOD DRIVE SE DECISION MADE: 30-APR-03 MIDDLEBURG HEIGHTS, OH 44130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENHANCE HUMAN SERUM ALBUMIN CONCEPTION TECHNOLOGIES 510(k) NO: K030850(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 08-APR-03 IRVINE, CA 92606 510(k) STATEMENT DEVICE: COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS COOPERSURGICAL, INC. 510(k) NO: K021237(TRADITIONAL) ATTN: HAIKO BELL PHONE NO : 203-944-9320 KAISERSTR.9 SE DECISION MADE: 10-APR-03 TUNINGEN, GERMANY D-78609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL EXAM GLOVES, WHITE COPIOUMED INTL., INC. 510(k) NO: K030927(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 17-APR-03 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WORRY-REMOVER IRRIGATOR CORISEN GROUP, LTD. 510(k) NO: K030056(TRADITIONAL) ATTN: WEI N ZUO PHONE NO : 513-755-7073 6537 MEADOWBROOK COURT SE DECISION MADE: 22-APR-03 WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COZART EIA OPIATES ORAL FLUID KIT COZART BIOSCIENCE LTD. 510(k) NO: K024339(TRADITIONAL) ATTN: ROBERTO LIDDI PHONE NO : 44 012 35861483 45 MILTON PARK SE DECISION MADE: 07-APR-03 ABINGDON 510(k) STATEMENT OXFORDSHIRE OX14 4RU, UNITED KINGDOM OX14 4RU DEVICE: COZART EIA COCAINE ORAL FLIUD KIT COZART BIOSCIENCE LTD. 510(k) NO: K030234(TRADITIONAL) ATTN: ROBERTO LIDDI PHONE NO : 012 358 61483 45 MILTON PARK SE DECISION MADE: 28-APR-03 ABINGDON, OXON, UNITED KINGDOM OX1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODE CRITICARE SYSTEMS, INC. 510(k) NO: K030613(SPECIAL) ATTN: ALEX KAPLAN PHONE NO : 262-798-8282 20925 CROSSROADS CIRCLE SE DECISION MADE: 17-APR-03 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARD CRYOCATH TECHNOLOGIES, INC. 510(k) NO: K030303(TRADITIONAL) ATTN: JEAN-PIERRE DESMARAIS PHONE NO : 514 694 1212 X226 16771 CHEMIN STE MARIE SE DECISION MADE: 29-APR-03 KIRKLAND, CANADA H9H 5H3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) CYTOMEDIX 510(k) NO: K030340(TRADITIONAL) ATTN: CARELYN P FYLLING PHONE NO : 218-547-4142 10952 STEAMBOAT LOOP, N.W. SE DECISION MADE: 11-APR-03 WALKER, MN 56484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 DAITO CO., LTD. 510(k) NO: K024342(TRADITIONAL) ATTN: EDWARD EPSTEIN PHONE NO : 860-643-4700 945 MAIN STREET SE DECISION MADE: 23-APR-03 STE. 312 510(k) SUMMARY AVAILABLE FROM FDA MANCHESTER, CT 06040 DEVICE: DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSOR DATEX-OHMEDA 510(k) NO: K023454(ABBREVIATED) ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 23-APR-03 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUASENS FLUID MONITORING SYSTEM DAVOL, INC. 510(k) NO: K031213(TRADITIONAL) ATTN: BRIAN A KANERVIKO PHONE NO : 401-463-7000 SUBSIDIARY OF C.R. BARD SE DECISION MADE: 30-APR-03 100 SOCKANOSSETT CROSSROAD 510(k) SUMMARY AVAILABLE FROM FDA CRANSTON, RI 02920 THIRD PARTY REVIEW DEVICE: TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATH DELTEC, INC. 510(k) NO: K030983(SPECIAL) ATTN: LISA STONE PHONE NO : 651-628-7224 1265 GREY FOX RD. SE DECISION MADE: 25-APR-03 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIEC DEN-TAL-EZ, INC. 510(k) NO: K030133(TRADITIONAL) ATTN: WILLIAM GUSCOTT PHONE NO : 717-291-1161 1816 COLONIAL VILLAGE LN. SE DECISION MADE: 29-APR-03 LANCASTER, PA 17601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ACROMED VBR SYSTEM DEPUY ACROMED 510(k) NO: K030833(SPECIAL) ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704 325 PARAMOUNT DR. SE DECISION MADE: 10-APR-03 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K030979(SPECIAL) ATTN: KARLA A HAM PHONE NO : 574-371-4925 700 ORTHOPAEDIC DR. SE DECISION MADE: 24-APR-03 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEROYAL GOWNS, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC. 510(k) NO: K030364(TRADITIONAL) ATTN: AUDREY DANIELS PHONE NO : 865-362-1373 200 DEBUSK LANE SE DECISION MADE: 28-APR-03 POWELL, TN 37849 510(k) STATEMENT DEVICE: DEROYAL DRAPES, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC. 510(k) NO: K030365(TRADITIONAL) ATTN: AUDREY DANIELS PHONE NO : 865-362-1373 200 DEBUSK LANE SE DECISION MADE: 29-APR-03 POWELL, TN 37849 510(k) STATEMENT DEVICE: DRIP ALERT DRIP ALERT, INC. 510(k) NO: K030136(TRADITIONAL) ATTN: POLLY D HESEMAN PHONE NO : 954-468-1359 500 E. BROWARD BLVD. SE DECISION MADE: 07-APR-03 SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA FT. LAUDERDALE, FL 33394 DEVICE: PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL E-Z-EM, INC. 510(k) NO: K030854(SPECIAL) ATTN: JUDY HAUSER PHONE NO : 516-333-8230 717 MAIN ST. SE DECISION MADE: 16-APR-03 WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS EAGLE VISION, INC. 510(k) NO: K030353(TRADITIONAL) ATTN: BILLY HANNAFORD PHONE NO : 901-380-7000 8500 WOLF LAKE DRIVE SE DECISION MADE: 25-APR-03 SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA MEMPHIS, TN 38133 DEVICE: EDWARDS INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. 510(k) NO: K031087(TRADITIONAL) ATTN: DAUN PUTNAM PHONE NO : 949-250-2500 ONE EDWARDS WAY SE DECISION MADE: 24-APR-03 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPI ACTION PATCH IONTOPHORESIS SYSTEM EMPI 510(k) NO: K030395(TRADITIONAL) ATTN: SUSAN ONEL PHONE NO : 202-778-9134 1800 MASSACHUSETTS AVE NW SE DECISION MADE: 08-APR-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036-1221 DEVICE: CONSTRAINED LINER ENCORE MEDICAL, L.P. 510(k) NO: K023794(ABBREVIATED) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 01-APR-03 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBODISSECTING ENDOSCOPE ENDO SURGICAL DEVICES, INC. 510(k) NO: K020925(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 29-APR-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K030129(TRADITIONAL) ATTN: KAREN J MCKELVEY PHONE NO : 651-523-6904 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 22-APR-03 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3 ENRAF-NONIUS B.V. 510(k) NO: K030297(TRADITIONAL) ATTN: RICK COELET PHONE NO : 31 15 2698400 1. RONTGENWEG SE DECISION MADE: 28-APR-03 DELFT, NETHERLANDS NL-2624 BD 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVAN HEART RATE MONITOR ENVAN, LLC 510(k) NO: K030656(TRADITIONAL) ATTN: MARIE MARLOW PHONE NO : 202-546-1262 719 A STREET, NE SE DECISION MADE: 08-APR-03 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUOHY EPIDURAL NEEDLE EPIMED INTERNATIONAL, INC. 510(k) NO: K030562(TRADITIONAL) ATTN: CHRISTOPHER B LAKE PHONE NO : 518-725-0209 141 SAL LANDRIO DRIVE SE DECISION MADE: 03-APR-03 CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA JOHNSTOWN, NY 12095 DEVICE: OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT EXACTECH, INC. 510(k) NO: K030686(SPECIAL) ATTN: GARY MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 02-APR-03 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 FORTUNE MEDICAL INSTRUMENT CORP. 510(k) NO: K022112(TRADITIONAL) ATTN: JESSICA CHAN PHONE NO : 886 2 28360488 12-9, LIN 5, MAO-CHANG VILLAGE SE DECISION MADE: 03-APR-03 SAN-CHIH HSIANG 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: GALEMED PEAK FLOW METER, MODELS 3751/3752 GALEMED CORP. 510(k) NO: K022124(TRADITIONAL) ATTN: BRUCE KUO PHONE NO : 886 399 08618 87, LI-GONG 2ND RD., SE DECISION MADE: 03-APR-03 WU-JIA, I-LAN, CHINA (TAIWAN) 268 510(k) STATEMENT DEVICE: GE LOGIQ 9 MODEL 2375600 GE MEDICAL SYSTEMS, INC. 510(k) NO: K030934(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 17-APR-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE 3.0T GENERAL PURPOSE FLEX COIL GE MEDICAL SYSTEMS, INC. 510(k) NO: K030953(SPECIAL) ATTN: LARRY KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 10-APR-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR GELFLEX LABORATORIES 510(k) NO: K030027(TRADITIONAL) ATTN: PETER G BRYANT PHONE NO : 61 8 94434944 3 HUTTON ST., OSBORNE PARK SE DECISION MADE: 01-APR-03 PERTH, WESTERN, WA, AUSTRALIA 6017510(k) STATEMENT DEVICE: FLEXIBLE TIP THERMOMETER, MODEL 011206 GLOBAL TREASURE INDUSTRIES LTD. 510(k) NO: K030673(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT STREET SE DECISION MADE: 04-APR-03 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLDWAY PATIENT MONITOR, MODEL # UT4000F GOLDWAY US, INC. 510(k) NO: K021154(TRADITIONAL) ATTN: Y. JUSTIN CHEN PHONE NO : 408-286-8933 12 SOUTH FIRST STREET, SE DECISION MADE: 11-APR-03 SUITE 1205 510(k) STATEMENT SAN JOSE, CA 95113 DEVICE: GROMAN PREPMASTER GROMAN INC. 510(k) NO: K030292(TRADITIONAL) ATTN: BARRY B GROMAN PHONE NO : 954-649-8008 1917 NW 80 AVE SE DECISION MADE: 15-APR-03 MARGATE, FL 33063 510(k) STATEMENT DEVICE: HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. 510(k) NO: K030198(TRADITIONAL) ATTN: RICHARD D BLISS, JR. PHONE NO : 954-385-1690 510 STONEMONT DRIVE SE DECISION MADE: 01-APR-03 WESTON, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANSON MEDICAL CALF IMPLANT HANSON MEDICAL, INC. 510(k) NO: K030808(TRADITIONAL) ATTN: JOHN HARRISON PHONE NO : 805-961-9334 5662 CALLE REAL, #331 SE DECISION MADE: 21-APR-03 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANSON MEDICAL GLUTEAL IMPLANT HANSON MEDICAL, INC. 510(k) NO: K030809(TRADITIONAL) ATTN: JOHN HARRISON PHONE NO : 805-961-9334 5662 CALLE REAL, #331 SE DECISION MADE: 21-APR-03 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM HAYES MEDICAL, INC. 510(k) NO: K030151(TRADITIONAL) ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7156 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 10-APR-03 EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT DEVICE: CONSENSUS UNIPOLAR HEAD, COCR HAYES MEDICAL, INC. 510(k) NO: K030205(TRADITIONAL) ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7100 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 01-APR-03 EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT DEVICE: HL888HA HEALTH & LIFE CO., LTD. 510(k) NO: K030498(SPECIAL) ATTN: SUSAN CHEN PHONE NO : 886 232 349600 6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 11-APR-03 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) 235 DEVICE: HL888HM HEALTH & LIFE CO., LTD. 510(k) NO: K030499(SPECIAL) ATTN: SUSAN CHEN PHONE NO : 886 232 349600 6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 17-APR-03 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) 235 DEVICE: HL888JF HEALTH & LIFE CO., LTD. 510(k) NO: K030541(SPECIAL) ATTN: SUSAN CHEN PHONE NO : 886 232 349600 61 6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 24-APR-03 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) 235 DEVICE: VINCO BRAND ACUPUNCTURE NEEDLE HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K024207(TRADITIONAL) ATTN: ERIC CHENG PHONE NO : 408-433-3355 606 CHARCOT AVE. SE DECISION MADE: 14-APR-03 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K030572(TRADITIONAL) ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580 203 MAIN STREET, PMB 166 SE DECISION MADE: 01-APR-03 FLEMINGTON, NJ 08822 510(k) STATEMENT DEVICE: GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES HENNIG ENTERPRISES EUROPE S.R.L. 510(k) NO: K020421(TRADITIONAL) ATTN: GEORGE O'NEIL PHONE NO : 61 8 93881700 25 SHANN ST., FLOREAT SE DECISION MADE: 29-APR-03 PERTH, AUSTRALIA 6014 510(k) STATEMENT DEVICE: P2 POLYETHER HERAEUS KULZER, INC. 510(k) NO: K030318(TRADITIONAL) ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662 4315 S. LAFAYETTE BLVD. SE DECISION MADE: 03-APR-03 SOUTH BEND, IN 46614 510(k) STATEMENT DEVICE: HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 HILL-ROM AIR-SHIELDS 510(k) NO: K021622(TRADITIONAL) ATTN: MONICA FERRANTE PHONE NO : 215-682-8691 330 JACKSONVILLE RD. SE DECISION MADE: 01-APR-03 HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L HOME CARE TECHNOLOGY CO., LTD. 510(k) NO: K023001(TRADITIONAL) ATTN: SHU-CHEN CHENG PHONE NO : 614-451-1918 2064 TAMARIN DR. SE DECISION MADE: 08-APR-03 COLUMBUS, OH 43235 510(k) STATEMENT DEVICE: MODIFICATION TO XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K031090(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 59 ROUTE 17 SE DECISION MADE: 24-APR-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPEDIC WIRE HOWMEDICA OSTEONICS CORP. 510(k) NO: K031127(SPECIAL) ATTN: DEBRA BING PHONE NO : 201-831-5413 59 ROUTE 17 SE DECISION MADE: 28-APR-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO BUDDY, MODELS TB-100, TB-110, TB-120 HUBDIC CO., LTD 510(k) NO: K023412(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 239-948-2001 11820 RED HIBISCUS DRIVE SE DECISION MADE: 09-APR-03 BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APNEACHECK IM SYSTEMS 510(k) NO: K022294(TRADITIONAL) ATTN: DAVID T KRAUSMAN PHONE NO : 410-296-7723 1055 TAYLOR AVENUE SE DECISION MADE: 25-APR-03 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA BALTIMORE, MD 21286 DEVICE: ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR IMAGYN SURGICAL 510(k) NO: K021174(TRADITIONAL) ATTN: JULIE POWELL PHONE NO : 616-629-2787 8850 M-89 SE DECISION MADE: 29-APR-03 RICHLAND, MI 49083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP-3 HD ELECTRIC WHEELCHAIR IMC-HEARTWAY, LLC 510(k) NO: K030427(SPECIAL) ATTN: JUAN CARLOS RIVERA PHONE NO : 239-275-6767 6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 18-APR-03 FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEED LINK IMPLANT SCIENCES CORP. 510(k) NO: K023073(TRADITIONAL) ATTN: JOHN J MUNRO PHONE NO : 781-246-0700 107 AUDUBON ROAD, #5 SE DECISION MADE: 07-APR-03 WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 IMTEC CORP. 510(k) NO: K030243(TRADITIONAL) ATTN: J.BRAD VANCE PHONE NO : 580-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 23-APR-03 ARDMORE, OK 73401 510(k) STATEMENT DEVICE: INSORB ABSORBABLE STAPLES, MODEL SP-B20 INCISIVE SURGICAL, INC. 510(k) NO: K024117(TRADITIONAL) ATTN: JIM PETERSON PHONE NO : 952-591-2543 1409 FAIRFIELD ROAD SE DECISION MADE: 22-APR-03 MINNETONKA, MN 55305 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIGRA INDUS MEDICARE LTD. 510(k) NO: K022614(ABBREVIATED) ATTN: P. JANARDHAN REDDY PHONE NO : 914 027 760241 144, S.P. RD., BEGUMPET SE DECISION MADE: 08-APR-03 HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT DEVICE: INFINTT CO., LTD. STARPACS SYSTEM INFINITT COMPANY 510(k) NO: K031013(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 17-APR-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA PLEX ENA PROFILE 5 INOVA DIAGNOSTICS, INC. 510(k) NO: K030681(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 858-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 24-APR-03 SAN DIEGO, CA 92131 510(k) STATEMENT DEVICE: IVS INTRODUCER SET, MODEL 1003 INTEGRATED VASCULAR SYSTEMS, INC. 510(k) NO: K030723(TRADITIONAL) ATTN: SUSAN TURNER PHONE NO : 408-328-9090 743 NORTH PASTORIA AVENUE SE DECISION MADE: 03-APR-03 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K030181(TRADITIONAL) ATTN: LEN HICKEY PHONE NO : 512-326-3244 4020 SOUTH INDUSTRIAL DR. SE DECISION MADE: 17-APR-03 SUITE 160 510(k) STATEMENT AUSTIN, TX 78744 DEVICE: HEMOCHRON RESPONSE/SYSTEM INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K030818(SPECIAL) ATTN: JOHN CLAY PHONE NO : 800-272-1252 8 OLSEN AVE. SE DECISION MADE: 02-APR-03 EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATH INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K030984(SPECIAL) ATTN: PAMELA MISAJON PHONE NO : 760-918-1820 6354 CORTE DEL ABETO SE DECISION MADE: 24-APR-03 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: BIOUNIVERSAL PKF IVOCLAR VIVADENT, INC. 510(k) NO: K030435(TRADITIONAL) ATTN: ANDERJEET GULATI PHONE NO : 800-533-6825 175 PINEVIEW DR. SE DECISION MADE: 15-APR-03 AMHERST, NY 14228 510(k) STATEMENT DEVICE: BIO UNIVERSAL IVOCLAR VIVADENT, INC. 510(k) NO: K030436(TRADITIONAL) ATTN: ANDERJEET GULATI PHONE NO : 800-533-6825 175 PINEVIEW DR. SE DECISION MADE: 15-APR-03 AMHERST, NY 14228 510(k) STATEMENT DEVICE: LEFORTE SYSTEM BONE SCREW JEIL MEDICAL CORPORATION 510(k) NO: K023365(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 18-APR-03 DEERFILED, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JI-EE ELECTRIC SCOOTER, ESTHETE ES 1 JI-EE INDUSTRY CO., LTD. 510(k) NO: K024325(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-APR-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: HTS ARRAY COIL JOCKEY CLUB MRI ENGINEERING CENTER510(k) NO: K030540(TRADITIONAL) ATTN: FRANCIS LEE PHONE NO : 852 229 30324 POKFULAM ROAD SE DECISION MADE: 16-APR-03 UNIVERSITY OF HONG KONG 510(k) STATEMENT HONG KONG, HONG KONG DEVICE: KSEA POWERSHAVER SYSTEM S2 KARL STORZ ENDOSCOPY 510(k) NO: K030009(TRADITIONAL) ATTN: RENATE A MACLAREN PHONE NO : 310-410-2731 600 CORPORATE POINTE SE DECISION MADE: 02-APR-03 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT O KAWASUMI LABORATORIES AMERICA, INC510(k) NO: K030385(TRADITIONAL) ATTN: JACK PAVLO PHONE NO : 813-630-5554 5905 C HAMPTON OAKS PKWY. SE DECISION MADE: 15-APR-03 TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, LASER PERIPHERALS LLC. 510(k) NO: K030959(SPECIAL) ATTN: JEFFREY M STEIN PHONE NO : 763-525-8460 1000 BOONE AVENUE NORTH SE DECISION MADE: 25-APR-03 SUITE 300 510(k) STATEMENT GOLDEN VALLEY, MN 55427 DEVICE: SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES LEONHARD LANG GMBH 510(k) NO: K030362(ABBREVIATED) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 14-APR-03 STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVO COMBI LEVO AG 510(k) NO: K030893(TRADITIONAL) ATTN: THOMAS RAEBER PHONE NO : 41 56 6184411 ANGLIKERSTRASSE 20 SE DECISION MADE: 02-APR-03 5610 WOHLEN, SWITZERLAND CH-5610 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LINA-BAG, MODELS LB-60, LB-100 LINA MEDICAL CML APS 510(k) NO: K030422(TRADITIONAL) ATTN: NIELS KORNERUP PHONE NO : 454 329 6666 FORMERVANGEN 5 SE DECISION MADE: 14-APR-03 GLOSTRUP, DENMARK 2600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONG WELL LW-6DXX SERIES BODY FAT ANALYZER LONG WELL ELECTRONICS CORP. 510(k) NO: K030203(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 21-APR-03 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS LUMENIS, LTD. 510(k) NO: K030147(TRADITIONAL) ATTN: ANNA WORDEN PHONE NO : 925-426-8927 2400 CONDENSA STREET SE DECISION MADE: 15-APR-03 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI-CADDY MAMMENDORFER INSTITUTE FOR PHYSICS510(k) NO: K030323(TRADITIONAL) ATTN: ROBERT N CLARK PHONE NO : 303-234-9412 13605 WEST 7TH AVENUE SE DECISION MADE: 02-APR-03 GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS WITH OR WITHOUT SYRINGE MARINA MEDICAL INSTRUMENTS, INC. 510(k) NO: K021876(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 678-808-8180 1308 MORNINGSIDE PARK DR SE DECISION MADE: 08-APR-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDAMICUS FLOWGUARD PEELABLE INTRODUCER MEDAMICUS, INC. 510(k) NO: K030905(SPECIAL) ATTN: KARYL HASKELL PHONE NO : 763-559-2257 15301 HWY. 55 WEST SE DECISION MADE: 09-APR-03 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LU MEDCOMP 510(k) NO: K030270(TRADITIONAL) ATTN: MEGHAN J TINTLE PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 11-APR-03 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTR MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K030942(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 28-APR-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: ELFCARE DEVICE, MODELS 314A THROUGH 314G MEDISEB LTD. 510(k) NO: K023231(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 04-APR-03 20 HATA'AS ST. 510(k) STATEMENT KFAR SABA,, ISRAEL 44425 DEVICE: BIOFLEX PROFESSIONAL THERAPY SYSTEM MEDITECH INTERNATIONAL INC 510(k) NO: K023621(TRADITIONAL) ATTN: RICHARD KEEN PHONE NO : 203-329-2700 1151 HOPE STREET SE DECISION MADE: 10-APR-03 STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LIN MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K030696(SPECIAL) ATTN: PREETI JAIN PHONE NO : 763-391-9533 7611 NORTHLAND DR. N SE DECISION MADE: 11-APR-03 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K030735(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 18-APR-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES MEDTRONIC SOFAMOR DANEK 510(k) NO: K030736(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 02-APR-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERGRAFT MATRIX MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K023553(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 22-APR-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES MEDTRONIC XOMED, INC. 510(k) NO: K031003(SPECIAL) ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 11-APR-03 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5F MEDTRONIC LAUNCHER GUIDE CATHETER MEDTRONIC, INC. 510(k) NO: K030779(SPECIAL) ATTN: FRED L BOUCHER PHONE NO : 978-739-3116 37A CHERRY HILL DR. SE DECISION MADE: 24-APR-03 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVA EMPTY SOLUTION CONTAINER METRIX CO. 510(k) NO: K030888(SPECIAL) ATTN: JAMES J OLDHAM PHONE NO : 563-556-8800 4400 CHAVENELLE RD. SE DECISION MADE: 02-APR-03 DUBUQUE, IA 52002 510(k) STATEMENT DEVICE: VECTORSONIC, MODEL VU-270 METRON MEDICAL AUSTRALIA P/L 510(k) NO: K030880(SPECIAL) ATTN: DAVE TOMAN PHONE NO : 613 977 51234 57 ASTER AVE. SE DECISION MADE: 18-APR-03 CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT DEVICE: CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K030110(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 914-667-3999 521 HOMESTEAD AVE. SE DECISION MADE: 03-APR-03 MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOMAD ND1000M AUGMENTED VISION SYSTEM MICROVISION INCORPORATED 510(k) NO: K030940(TRADITIONAL) ATTN: KARL BYLUND PHONE NO : 425-415-6634 19910 NORTH CREEK PARKWAY SE DECISION MADE: 09-APR-03 BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CERACAST-V MOUNTAIN MEDICO, INC. 510(k) NO: K030416(TRADITIONAL) ATTN: PAUL C CHANG PHONE NO : 909-931-0688 600 NORTH MOUNTAIN AVE., #D204 SE DECISION MADE: 14-APR-03 UPLAND, CA 91786 510(k) STATEMENT DEVICE: ALGO 3I NEWBORN HEARING SCREENER NATUS MEDICAL, INC. 510(k) NO: K030823(SPECIAL) ATTN: RON KOHLHARDT PHONE NO : 650-802-0400 1501 INDUSTRIAL RD. SE DECISION MADE: 09-APR-03 SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC PLICATION SYSTEM NDO SURGICAL, INC. 510(k) NO: K023234(TRADITIONAL) ATTN: ERIC BANNON PHONE NO : 508-337-8881 125 HIGH ST., SE DECISION MADE: 17-APR-03 SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA MANSFIELD, MA 02048 DEVICE: SAFFRON NM GUIDING CATHETER NEICH MEDICAL (SHENZHEN) COMPANY L510(k) NO: K030715(TRADITIONAL) ATTN: RAYMOND LIN PHONE NO : 86 755 83580181 1 JINKUI ROAD, FUTIAN FREE SE DECISION MADE: 24-APR-03 TRADE ZONE 510(k) STATEMENT SHENZHEN, GUANGDONG, CHINA 518038 DEVICE: SUPEROPEN 0.35T, MODEL NSM-P035 NEUSOFT DIGITAL MEDICAL SYSTEM CO.510(k) NO: K030918(TRADITIONAL) ATTN: WANG ZHIQIANG PHONE NO : 86 24 83665003 NO.3-11, WENHUA ROAD SE DECISION MADE: 01-APR-03 HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW DEVICE: NICOLET PIONEER TC8080 NICOLET BIOMEDICAL 510(k) NO: K020754(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 21-APR-03 STOUGHTON, WI 53589 510(k) STATEMENT DEVICE: PETIT SOPHIA NISHITOMO CO., INC. 510(k) NO: K021978(TRADITIONAL) ATTN: LLOYD DUPLANTIS PHONE NO : 985-872-4547 3696 WEST MAIN STREET SE DECISION MADE: 08-APR-03 GRAY, LA 70359 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAVISION, MODEL 2.0 NOVAVISION, INC. 510(k) NO: K023623(TRADITIONAL) ATTN: SANDRA J.P. DENNIS PHONE NO : 202-739-5009 1111 PENNSYLVANIA AVE N.W. SE DECISION MADE: 22-APR-03 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPHTEC ENCLAVATION NEEDLE OPHTEC USA 510(k) NO: K030471(TRADITIONAL) ATTN: RICK MCCARLEY PHONE NO : 561-989-8767 6421 CONGRESS AVE. STE 112 SE DECISION MADE: 17-APR-03 BOCA RATON, FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLANATION TONOMETER OPTILASA S.L. 510(k) NO: K023676(TRADITIONAL) ATTN: JOSE M BOBES PHONE NO : 34 639 633696 338 ARTURO SORIA ST. SE DECISION MADE: 24-APR-03 MADRID, SPAIN 28033 510(k) STATEMENT DEVICE: F1 DIODE LASER SYSTEM OPUS MEDICAL, INC. 510(k) NO: K030235(TRADITIONAL) ATTN: RENE VAN DE ZANDE PHONE NO : 301-762-2828 1684 EAST GUDE DRIVE SE DECISION MADE: 23-APR-03 SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY E ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K023308(TRADITIONAL) ATTN: JIM CLOSSICK PHONE NO : 954-730-0711 5363 N.W. 35TH AVE. SE DECISION MADE: 14-APR-03 FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROCAP PLUS/NPB-75 ORIDION MEDICAL 1987 LTD. 510(k) NO: K024300(SPECIAL) ATTN: SANDY BROWN PHONE NO : 972 258 99115 7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 03-APR-03 HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA JERUSALEM, ISRAEL 91450 DEVICE: ODI 7.0MM CANNULATED SCREW SYSTEM ORTHOPEDIC DESIGNS, INC. 510(k) NO: K030619(TRADITIONAL) ATTN: PATRICK J COSGROVE PHONE NO : 888-635-8535 6965 1ST. AVE. NORTH SE DECISION MADE: 01-APR-03 ST. PETERSBURG, FL 33710-8303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMBIBE II SYRINGE ORTHOVITA, INC. 510(k) NO: K030208(TRADITIONAL) ATTN: ANDREINA IDE PHONE NO : 610-407-5231 45 GREAT VALLEY PKWY. SE DECISION MADE: 16-APR-03 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED CRANIAL FLAP FIXATION SYSTEM OSTEOMED CORP. 510(k) NO: K022277(TRADITIONAL) ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401 3750 REALTY RD. SE DECISION MADE: 01-APR-03 ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES P.T. GREENLEAF 510(k) NO: K020418(TRADITIONAL) ATTN: GEORGE O'NEIL PHONE NO : 618 938 81700 25 SHANN ST., FLOREAT SE DECISION MADE: 29-APR-03 PERTH, WESTERN AUSTRALIA, AUSTRALI510(k) STATEMENT DEVICE: PROANGLE DISPOSABLE PROPHY ANGLE PAC-DENT INTERNATIONAL (SUZHOU), L510(k) NO: K030603(TRADITIONAL) ATTN: XU WANG PHONE NO : 86 512 68085091 125 BINHE ROAD SE DECISION MADE: 14-APR-03 NEW DISTRICT OF SUZHOU CITY 510(k) SUMMARY AVAILABLE FROM FDA JIANGSU PROVINCE, CHINA 215011 DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K030620(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 14-APR-03 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L1 SYSTEM PELIKAN TECHNOLOGIES, INC 510(k) NO: K024170(TRADITIONAL) ATTN: JACK GREEN PHONE NO : 650-842-1000 1072 EAST MEADOW CIRCLE SE DECISION MADE: 14-APR-03 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBERFILL AGP PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K023818(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 03-APR-03 WALLINGFORD, CT 06492-0724 510(k) STATEMENT DEVICE: AT HOME DRUG CUP, MODEL 9150X PHAMATECH 510(k) NO: K030447(SPECIAL) ATTN: CARL MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT ST., #101 SE DECISION MADE: 14-APR-03 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIPHYSIONIZER 2.0 AND ELECTRODES PHYSION, INC. 510(k) NO: K022950(TRADITIONAL) ATTN: ERIC J NEMETH PHONE NO : 973-376-7700 51 JOHN F. KENNEDY PARKWAY SE DECISION MADE: 18-APR-03 SHORT HILLS, NJ 07078-5006 510(k) STATEMENT DEVICE: MODIFICATION TO MODULAR PLUS REVISION STEM PLUS ORTHOPEDICS 510(k) NO: K030971(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 24-APR-03 ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REX, VERSION 3.0 POINTDX, INC 510(k) NO: K030457(TRADITIONAL) ATTN: FRANCIS BONK PHONE NO : 336-723-1450 635 WEST FOURTH STREET SE DECISION MADE: 08-APR-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA WINSTON-SALEM, NC 27101 DEVICE: MICROALBUMIN REAGENT SET AND CALIBRATORS POINTE SCIENTIFIC, INC. 510(k) NO: K023860(TRADITIONAL) ATTN: RON JAMISON PHONE NO : 313-383-7220 1025 JOHN A. PAPALAS DR. SE DECISION MADE: 28-APR-03 LINCOLN PARK, MI 48146 510(k) STATEMENT DEVICE: PS 3000 DIGATAL PHOTOSPOT SYSTEM PRECISE OPTICS 510(k) NO: K030061(TRADITIONAL) ATTN: RICHARD KEEN PHONE NO : 203-329-2700 1151 HOPE STREET SE DECISION MADE: 07-APR-03 STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 PRECISION BIOLOGIC 510(k) NO: K023991(TRADITIONAL) ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422 900 WINDMILL RD., SUITE 100 SE DECISION MADE: 28-APR-03 DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABY POD PRISM ENTERPRISES, INC. 510(k) NO: K030283(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 22-APR-03 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISET DAT AMPHETAMINE QUANTIMETRIX CORP. 510(k) NO: K030826(TRADITIONAL) ATTN: GEBHARD NEYER PHONE NO : 310-536-0006 2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 03-APR-03 REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RABBIT MOBILE STANDING FRAME R82 A/S 510(k) NO: K030882(TRADITIONAL) ATTN: KIRK L MACKENZIE PHONE NO : 704-882-6681 12801 EAST INDEPENDENCE BLVD. SE DECISION MADE: 04-APR-03 STALLINGS, NC 28105 510(k) STATEMENT DEVICE: RADIONICS SINGLE USE GROUND PAD (DGP-HP) RADIONICS, INC. 510(k) NO: K030697(SPECIAL) ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 04-APR-03 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RDI EXTENDED RANGE CRP CALIBRATOR SET REFERENCE DIAGNOSTICS, INC. 510(k) NO: K030772(ABBREVIATED) ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000 19 CROSBY DR. SUITE 30 SE DECISION MADE: 11-APR-03 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: MIRAGE ACTIVA MASK RESMED LTD. 510(k) NO: K030798(SPECIAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2400 14040 DANIELSON STREET SE DECISION MADE: 09-APR-03 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMO-STREAM HEMODIALYSIS CATHETER SET REX MEDICAL 510(k) NO: K023847(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 30-APR-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: RITA STARBURST SDE ELECTROSURGICAL DEVICE RITA MEDICAL SYSTEMS 510(k) NO: K030967(SPECIAL) ATTN: ERIN MAZZONE PHONE NO : 650-314-3400 967 NORTH SHORELINE BLVD. SE DECISION MADE: 21-APR-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RITA CLIPS FOR INFUSION PUMPS RITA MEDICAL SYSTEMS INC 510(k) NO: K030936(TRADITIONAL) ATTN: VICKI HACKER PHONE NO : 650-314-3400 967 N. SHORELINE BLVD SE DECISION MADE: 01-APR-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ONLINE DAT II CANNABINOIDS II ROCHE DIAGNOSTICS CORP. 510(k) NO: K030213(ABBREVIATED) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 11-APR-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ONLINE TDM PHENYTOIN ROCHE DIAGNOSTICS CORP. 510(k) NO: K030428(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 800-428-5974 9115 HAGUE RD. SE DECISION MADE: 28-APR-03 PO BX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K030740(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 01-APR-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEC-TOP, STERIDENT, BENTO RONPAK, INC. 510(k) NO: K031022(SPECIAL) ATTN: THOMAS A AUGURT PHONE NO : 917-974-2425 4301 NEW BRUNSWICK AVE. SE DECISION MADE: 14-APR-03 SOUTH PLAINFIELD, NJ 07080 510(k) STATEMENT DEVICE: RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM SALTON, INC. 510(k) NO: K030437(TRADITIONAL) ATTN: GEORGIA C RAVITZ PHONE NO : 202-857-6000 1050 CONNECTICUT AVE., NW SE DECISION MADE: 10-APR-03 WASHINGTON, DC 20036-5339 510(k) STATEMENT DEVICE: URINE MONOVETTE BORIC ACID SARSTEDT, INC. 510(k) NO: K024237(TRADITIONAL) ATTN: PETER RUMSWINKEL PHONE NO : 828-465-4000 1025 ST. JAMES CHURCH RD. SE DECISION MADE: 14-APR-03 NEWTON, NC 28658 510(k) STATEMENT DEVICE: SELITHERM, MODEL C100 SELICOR, INC. 510(k) NO: K030382(TRADITIONAL) ATTN: JAMES B BINGHAM PHONE NO : 512-514-6650 7000 NORTH MOPAC, SECOND FLR. SE DECISION MADE: 01-APR-03 AUSTIN, TX 78731 510(k) STATEMENT DEVICE: MODIFICATION TO HIOX SENSOR MEDICS CORP. 510(k) NO: K030943(TRADITIONAL) ATTN: EARL W DRAPER PHONE NO : 714-283-2228 22705 SAVI RANCH PKWY. SE DECISION MADE: 22-APR-03 YORBA LINDA, CA 92687 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 SERADYN 510(k) NO: K030405(TRADITIONAL) ATTN: LES PADILLA PHONE NO : 317-610-3800 7998 GEORGETOWN RD. SE DECISION MADE: 28-APR-03 SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46268 DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K030094(TRADITIONAL) ATTN: GLORIA CHANG PHONE NO : 909-465-9188 18709 GREEN BAY DRIVE SE DECISION MADE: 01-APR-03 ROWLAND HIGHS, CA 91748 510(k) STATEMENT DEVICE: SYNGO COLONOGRAPHY SOFTWARE PACKAGE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K030982(TRADITIONAL) ATTN: JAMIE YIEH PHONE NO : 610-448-1785 51 VALLEY STREAM PARKWAY SE DECISION MADE: 08-APR-03 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TETRIS SPINAL IMPLANT SIGNUS MEDICAL LLC. 510(k) NO: K022793(TRADITIONAL) ATTN: ANN QUINLAN-SMITH PHONE NO : 763-287-3830 4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 08-APR-03 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: TRAVELSOME STANDARD SIM ITALIA S.R.L. 510(k) NO: K030233(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 25-APR-03 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SK MED M201 MIXER SK MED 510(k) NO: K022864(ABBREVIATED) ATTN: DIPAK GHOSH PHONE NO : 818-776-1325 16000 SHERMAN WAY #224 SE DECISION MADE: 11-APR-03 VAN NUYS, CA 91406 510(k) STATEMENT DEVICE: SWITCHBLADE SNOWDEN PENCER, INC. 510(k) NO: K030890(TRADITIONAL) ATTN: DAVID J BOOTH PHONE NO : 770-723-2741 5175 SOUTH ROYAL ATLANTA DR. SE DECISION MADE: 04-APR-03 TUCKER, GA 30084-3053 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TITAN HIGH RESOLUTION ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K030949(TRADITIONAL) ATTN: MICHAEL HOFFMAN PHONE NO : 425-951-1200 21919 30TH DRIVE SE. SE DECISION MADE: 07-APR-03 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RIVA-SELF CURE SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K030516(TRADITIONAL) ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300 729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 17-APR-03 BENSENVILLE, IL 60106 510(k) STATEMENT DEVICE: RADII SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K030568(TRADITIONAL) ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300 729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 24-APR-03 BENSENVILLE, IL 60106 510(k) STATEMENT DEVICE: SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT ST. SHINE OPTICAL CO., LTD. 510(k) NO: K030548(TRADITIONAL) ATTN: GAROLD L EDWARDS PHONE NO : 408-221-3860 2091 UPPER SCENIC DRIVE SE DECISION MADE: 04-APR-03 FELTON, CA 95018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SY STD MFG., INC. 510(k) NO: K023096(TRADITIONAL) ATTN: STEVE EK PHONE NO : 781-828-4400 1063 TURNPIKE ST. SE DECISION MADE: 10-APR-03 P.O. BOX 420 510(k) SUMMARY AVAILABLE FROM FDA STOUGHTON, MA 02072 DEVICE: STEREOTAXIS CATHETER ADVANCER SYSTEM STEREOTAXIS, INC. 510(k) NO: K021802(TRADITIONAL) ATTN: GARY M RAUVOLA PHONE NO : 314-615-6913 4041 FOREST PARK AVENUE SE DECISION MADE: 08-APR-03 ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERSTICK PERIO STICK TECH LTD. 510(k) NO: K030072(TRADITIONAL) ATTN: WILLIAM M TROETEL PHONE NO : 914-664-1640 80 PARKWAY WEST SE DECISION MADE: 10-APR-03 MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO STRYKER PAINPUMP2 STRYKER INSTRUMENTS 510(k) NO: K030885(SPECIAL) ATTN: NICOLE PETTY PHONE NO : 269-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 18-APR-03 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL SULTAN CHEMISTS, INC. 510(k) NO: K030414(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 201-871-1232 85 WEST FOREST AVE. SE DECISION MADE: 09-APR-03 ENGLEWOOD, NJ 07631 510(k) STATEMENT DEVICE: LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DES SURETEX, LTD. 510(k) NO: K030176(ABBREVIATED) ATTN: CYNTHIA A INGRAM PHONE NO : 334-615-2563 1500 INDUSTRIAL ROAD SE DECISION MADE: 17-APR-03 P.O. BOX 1252 510(k) SUMMARY AVAILABLE FROM FDA DOTHAN, AL 36302 DEVICE: POLRIS LV SYNERON MEDICAL LTD. 510(k) NO: K030186(TRADITIONAL) ATTN: AMIR WALDMAN PHONE NO : 972 490 97424 POB 550 SE DECISION MADE: 14-APR-03 YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERITAS COLLAGEN MATRIX SYNOVIS SURGICAL INNOVATIONS 510(k) NO: K030879(TRADITIONAL) ATTN: ANGELA MALLERY PHONE NO : 651-603-5212 2575 UNIVERSITY AVE. SE DECISION MADE: 24-APR-03 ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM SYNTHES (USA) 510(k) NO: K030069(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 08-APR-03 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM SYNTHES (USA) 510(k) NO: K030310(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 22-APR-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE SYNTHES (USA) 510(k) NO: K030390(TRADITIONAL) ATTN: BONNIE SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 01-APR-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS SYNTHES (USA) 510(k) NO: K030858(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 04-APR-03 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES ANTERIOR CSLP SYSTEM SYNTHES (USA) 510(k) NO: K030866(TRADITIONAL) ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700 1380 ENTERPRISE DRIVE SE DECISION MADE: 18-APR-03 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-SCIENTIFIC T-PAD T-SCIENTIFIC, INC. 510(k) NO: K030334(TRADITIONAL) ATTN: DENNIS METCALF PHONE NO : 713-302-0019 1146 GARDENCREST LANE SE DECISION MADE: 21-APR-03 HOUSTON, TX 77077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C. DIFFICILE TOX A/B II TECHLAB, INC. 510(k) NO: K030404(TRADITIONAL) ATTN: DAVID A WALL PHONE NO : 540-953-1664 1861 PRATT DR., STE. 1030 SE DECISION MADE: 24-APR-03 BLACKSBURG, VA 24060-6364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBD-QUIK CHEK TECHLAB, INC. 510(k) NO: K030704(TRADITIONAL) ATTN: DAVID M LYERLY PHONE NO : 800-832-4522 1861 PRATT DR., STE. 1030 SE DECISION MADE: 21-APR-03 BLACKSBURG, VA 24060-6364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMATREK IRIS-IV INFRARED IMAGING SYSTEM THERMATREK 510(k) NO: K030165(TRADITIONAL) ATTN: DAVID R BALZER PHONE NO : 203-263-5951 660 MAIN ST., SOUTH, #7 SE DECISION MADE: 16-APR-03 WOODBURY, CT 06798 510(k) STATEMENT DEVICE: GC OIA THERMO BIOSTAR, INC. 510(k) NO: K023947(TRADITIONAL) ATTN: JOHN G ADAMS PHONE NO : 303-530-3888 331 SOUTH 104TH STREET SE DECISION MADE: 17-APR-03 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) TINNITECH LTD 510(k) NO: K030791(TRADITIONAL) ATTN: LACHLAN JAMES PHONE NO : 61 2 92830601 55 MARKET STREET SE DECISION MADE: 17-APR-03 LEVEL 2 510(k) SUMMARY AVAILABLE FROM FDA SYDNEY, AUSTRALIA NSW 2000 DEVICE: FLAT PANEL DISPLAY, ME183L TOTOKU ELECTRIC CO., LTD 510(k) NO: K030272(TRADITIONAL) ATTN: MIKIO HASEGAWA PHONE NO : 011 81 268345484 300 OYA , UEDA-SHI, SE DECISION MADE: 25-APR-03 NAGANO-KEN, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL FLAT PANEL DISPLAY, ME315L TOTOKU ELECTRIC CO., LTD 510(k) NO: K030274(TRADITIONAL) ATTN: MIKIO HASEGAWA PHONE NO : 011 81 268345484 300 OYA, UEDA-SHI, SE DECISION MADE: 25-APR-03 NAGANO-KEN, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLAT PANEL DISPLAYS, CDL SERIES TOTOKU ELECTRIC CO., LTD 510(k) NO: K030276(TRADITIONAL) ATTN: MIKIO HASEGAWA PHONE NO : 011 81 268345484 300 OYA, UEDA-SHI, SE DECISION MADE: 25-APR-03 NAGANO-KEN, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CON TZ MEDICAL, INC. 510(k) NO: K021421(TRADITIONAL) ATTN: MADALYN DUNCAN PHONE NO : 503-639-0282 7272 S.W. DURHAM RD., #800 SE DECISION MADE: 18-APR-03 PORTLAND, OR 97224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WBR, MODEL HR U.C.G. TECHNOLOGIES LTD. 510(k) NO: K030870(SPECIAL) ATTN: DAN LAOR PHONE NO : 972 4 8546611 BUILDING # 30 MATAM SE DECISION MADE: 09-APR-03 HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL URIDYNAMICS, INC. 510(k) NO: K030650(TRADITIONAL) ATTN: MYRON RAPKIN PHONE NO : 317-915-7896 6786 HAWTHORNE PARK DRIVE SE DECISION MADE: 14-APR-03 INDIANAPOLIS, IN 46220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VTI 20 MHZ GATED DOPPLER VASCULAR TECHNOLOGY INCORPORATED 510(k) NO: K031091(TRADITIONAL) ATTN: DAVID L REGAN PHONE NO : 978-453-1055 175 CABOT ST. SE DECISION MADE: 23-APR-03 LOWELL, MA 01854 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: EPTFE VASCULAR PROSTHESIS; SEALPTFE VASCUTEK LTD. 510(k) NO: K030999(SPECIAL) ATTN: STEVEN ARICK PHONE NO : 734-741-6238 6200 JACKSON ROAD SE DECISION MADE: 09-APR-03 ANN ARBOR, MI 48103-9300 510(k) STATEMENT DEVICE: FRONTIER MODEL X5 VESTIL MANUFACTURING CORP. 510(k) NO: K030783(TRADITIONAL) ATTN: RICK MICHAEL PHONE NO : 260-668-5677 900 GROWTH PARKWAY SE DECISION MADE: 04-APR-03 ANGOLA, IN 46703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELOCITY ADVANTAGE VISION CARE DEVICES, INC. 510(k) NO: K023939(TRADITIONAL) ATTN: CHET CRACCHIOLO PHONE NO : 530-243-5047 1246 REDWOOD BLVD. SE DECISION MADE: 17-APR-03 REDDING, CA 96003 510(k) STATEMENT DEVICE: VITALCARE URETHRAL CATHETER VITALCARE, INC. 510(k) NO: K021938(TRADITIONAL) ATTN: MICHAEL MCAVENIA PHONE NO : 305-620-4007 15800 NW 13TH AVENUE SE DECISION MADE: 22-APR-03 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALCARE FOLEY CATHETER VITALCARE, INC. 510(k) NO: K021939(TRADITIONAL) ATTN: MICHAEL MCAVENIA PHONE NO : 305-620-4007 15800 NW 13TH AVENUE SE DECISION MADE: 22-APR-03 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALCARE URETHRAL CATHETER RED RUBBER VITALCARE, INC. 510(k) NO: K023872(TRADITIONAL) ATTN: MICHAEL MCAVENIA PHONE NO : 305-620-4007 15800 NW 13TH AVENUE SE DECISION MADE: 10-APR-03 MIAMI, FL 33169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON VITALCOR, INC. 510(k) NO: K030231(TRADITIONAL) ATTN: WILLIAM HUCK PHONE NO : 630-325-5500 100 EAST CHESTNUT AVE. SE DECISION MADE: 18-APR-03 WESTMONT, IL 60559 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOOP MICROWAVE ABLATION PROBE VIVANT MEDICAL, INC. 510(k) NO: K023311(TRADITIONAL) ATTN: STEVEN KIM PHONE NO : 650-694-2900 1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 09-APR-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. GORE & ASSOCIATES, INC. 510(k) NO: K030782(TRADITIONAL) ATTN: MIKE JOHNSON PHONE NO : 928-864-3615 3450 WEST KILTIE LANE SE DECISION MADE: 21-APR-03 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYSTEREOSCOPY PUMP HM4 W.O.M. WORLD OF MEDICINE AG 510(k) NO: K022449(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 617-868-3995 91 TROWBRIDGE STREET SE DECISION MADE: 10-APR-03 CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROSCOPY PUMP, MODEL A107 W.O.M. WORLD OF MEDICINE AG 510(k) NO: K030402(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 617-868-3995 91 TROWBRIDGE STREET SE DECISION MADE: 17-APR-03 CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, M WAKO CHEMICALS, USA, INC. 510(k) NO: K030320(TRADITIONAL) ATTN: LORI CREASY PHONE NO : 800-992-9256 1600 BELLWOOD RD. SE DECISION MADE: 11-APR-03 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WU'S POWERED WHEELCHAIR, MAMBO 3 WU'S TECH CO., LTD. 510(k) NO: K030707(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-APR-03 HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) STATEMENT DEVICE: WU'S POWERED WHEELCHAIR, MAMBO 5 WU'S TECH CO., LTD. 510(k) NO: K030709(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-APR-03 HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) STATEMENT DEVICE: X O ODONTOSURGE 4 XO CARE A/S 510(k) NO: K023672(TRADITIONAL) ATTN: JAMES DIEROFF PHONE NO : 949-376-4228 1100 S. COAST HIGHWAY STE. 204 SE DECISION MADE: 29-APR-03 LAGUNGA BEACH, CA 92651 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-BOX Z-KAT, INC. 510(k) NO: K030764(SPECIAL) ATTN: CHRISTINA VANCE PHONE NO : 954-927-2044 2901 SIMMS STREET SE DECISION MADE: 24-APR-03 HOLLYWOOD, FL 33020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 ZIMMER, INC. 510(k) NO: K030153(TRADITIONAL) ATTN: KAREN CAIN PHONE NO : 574-372-4219 P.O. BOX 708 SE DECISION MADE: 01-APR-03 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 254 TOTAL WITH SUMMARIES 188 TOTAL WITH STATEMENTS 66
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