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510(k)s Final Decisions Rendered for April 2003 |
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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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