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510(k)s Final Decisions Rendered for February 2004 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-FEB-2004 THROUGH 28-FEB-2004 DEVICE: FEMTEC LASER MICROKERATOME 20/10 PERFECT VISION OPTISCHE GERA510(k) NO: K033354(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 18-FEB-04 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERMES BOND 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K033974(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 06-FEB-04 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERMES 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K033996(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 24-FEB-04 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM ABBOT LABORATORIES 510(k) NO: K033909(TRADITIONAL) ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331 400 SAGINAW DR. SE DECISION MADE: 17-FEB-04 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP ACON LABORATORIES, INC. 510(k) NO: K032903(TRADITIONAL) ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 17-FEB-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXY ACON LABORATORIES, INC. 510(k) NO: K033047(TRADITIONAL) ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 17-FEB-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSPHERE TEMPO CARDIOLOGY WORKSTATION ADAC LABORATORIES 510(k) NO: K040142(TRADITIONAL) ATTN: COLEEN COLEMAN PHONE NO : 408-468-3051 540 ALDER DR. SE DECISION MADE: 06-FEB-04 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AUTOQUANT PLUS ADAC LABORATORIES 510(k) NO: K040326(TRADITIONAL) ATTN: JOY M SACMAR PHONE NO : 408-468-3053 540 ALDER DR. SE DECISION MADE: 25-FEB-04 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TITANIUM CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS 510(k) NO: K033749(TRADITIONAL) ATTN: PATRICK JANIN PHONE NO : 33 4 92120474 265 ROUTE DE LA BARONNE SE DECISION MADE: 23-FEB-04 ST. JEANNET, FRANCE 06640 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K031741(TRADITIONAL) ATTN: RENEE L FLUET PHONE NO : 858-458-7563 10221 WATERIDGE CIR. SE DECISION MADE: 09-FEB-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE ALTUS MEDICAL, INC. 510(k) NO: K033768(TRADITIONAL) ATTN: KATHY MAYNOR PHONE NO : 650-259-5586 821 COWAN RD. SE DECISION MADE: 17-FEB-04 BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. 510(k) NO: K033053(TRADITIONAL) ATTN: HOWARD SCHRAYER PHONE NO : 609-924-9510 401 NORTH TRYON ST. SE DECISION MADE: 25-FEB-04 10TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CHARLOTTE, NC 28202 DEVICE: AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE AMBU, INC. 510(k) NO: K032421(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-636-1144 611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 27-FEB-04 LINTHICUM, MD 21090-1356 510(k) STATEMENT DEVICE: AMSURE RED RUBBER URETHRAL CATHETER AMSINO INTERNATIONAL, INC. 510(k) NO: K030293(TRADITIONAL) ATTN: CHING CHING SEAH PHONE NO : 909-390-5688 4501 BRICKELL PRIVADO ST. SE DECISION MADE: 04-FEB-04 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: APEX MEDICAL CPAP RT 21XX APEX MEDICAL CORP. 510(k) NO: K022650(TRADITIONAL) ATTN: ALAN CHANG PHONE NO : 886 2 26954170 10TH FL., NO. 31, LANE 169, SE DECISION MADE: 04-FEB-04 KANG NING ST. 510(k) STATEMENT SHI-CHIH, TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: SURESTEP STREP A EXACT. AN ULTRA-SENSITIVE GROUP A STREPTOCOCCAL APPLIED BIOTECH 510(k) NO: K033855(TRADITIONAL) ATTN: JERRY ALPERIN PHONE NO : 858-587-6771 10237 FLANDERS CT. SE DECISION MADE: 13-FEB-04 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: CANNON II PLUS ARROW INTERNATIONAL, INC. 510(k) NO: K040078(SPECIAL) ATTN: BRANDON EPTING PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 13-FEB-04 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC. 510(k) NO: K031859(TRADITIONAL) ATTN: ROBERT J MICHALIK PHONE NO : 781-297-7265 378 PAGE STREET, STE 6 SE DECISION MADE: 18-FEB-04 STOUGHTON, MA 02072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE ARTHROTEK, INC. 510(k) NO: K033718(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 12-FEB-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BISX ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K040183(SPECIAL) ATTN: CHRISTINE VOZELLA PHONE NO : 303-926-5624 1775 ROCKIES COURT SE DECISION MADE: 25-FEB-04 LAFAYETTE, CO 80026 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADAM ASTRO-MED, INC. 510(k) NO: K033978(TRADITIONAL) ATTN: MICHAEL J SULLIVAN PHONE NO : 401-828-4000 600 EAST GREENWICH AVE. SE DECISION MADE: 18-FEB-04 WEST WARWICK, RI 02893 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAMAX .018 BILIARY STENT SYSTEM AVANTEC VASCULAR CORP. 510(k) NO: K032436(TRADITIONAL) ATTN: JAMES M SHY PHONE NO : 408-743-3100 1049 KIEL CT. SE DECISION MADE: 04-FEB-04 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER B. BRAUN MEDICAL, INC. 510(k) NO: K033527(TRADITIONAL) ATTN: AMY SMITH PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 05-FEB-04 ALLENTOWN, PA 18103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE.CLICK NEEDLE B. BRAUN MEDICAL, INC. 510(k) NO: K033575(TRADITIONAL) ATTN: JENNIFER A KOSOY PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 09-FEB-04 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. 510(k) NO: K033952(TRADITIONAL) ATTN: AMY SMITH PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 04-FEB-04 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC BACCHUS VASCULAR, INC. 510(k) NO: K033997(SPECIAL) ATTN: LISA CAPARRA PHONE NO : 408-980-8300 3110 CORONADO DR. SE DECISION MADE: 04-FEB-04 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES BAODING GUANZHONG GLOVE CO., LTD. 510(k) NO: K033723(TRADITIONAL) ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING ROAD SE DECISION MADE: 24-FEB-04 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK BAUSCH & LOMB, INC. 510(k) NO: K033941(TRADITIONAL) ATTN: DENNIS POZZO PHONE NO : 636-226-3183 3365 TREE CT. INDUSTRIAL BLVD. SE DECISION MADE: 10-FEB-04 ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAWMED E-Z BAG RESUSCITATOR BAWMED UK 510(k) NO: K031434(TRADITIONAL) ATTN: BARBARA WOODS PHONE NO : 44 144 6794567 6 GREAT HOUSE MEADOWS SE DECISION MADE: 06-FEB-04 UNITED KINGDOM, UNITED KINGDOM CF6510(k) STATEMENT DEVICE: BAYER SPECIFIC PROTEIN REFERENCE SERUM BAYER HEALTHCARE, LLC 510(k) NO: K033791(ABBREVIATED) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 13-FEB-04 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY BECKMAN COULTER, INC. 510(k) NO: K033036(TRADITIONAL) ATTN: BRENT TABER PHONE NO : 952-368-1323 1000 LAKE HAZELTINE DR. SE DECISION MADE: 03-FEB-04 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 BECTON DICKINSON & CO. 510(k) NO: K033784(TRADITIONAL) ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260 7 LOVETON CIR. SE DECISION MADE: 03-FEB-04 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE BECTON DICKINSON & CO. 510(k) NO: K040006(TRADITIONAL) ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 27-FEB-04 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXIVA CLOSED IV CATHETER SYSTEM BECTON DICKINSON INFUSION THERAPY 510(k) NO: K032843(TRADITIONAL) ATTN: LESLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE ST. SE DECISION MADE: 27-FEB-04 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- NITROFURANTOIN GRAM PO BECTON, DICKINSON AND COMPANY 510(k) NO: K033889(TRADITIONAL) ATTN: DAVID STREETT PHONE NO : 410-316-4619 7 LOVETON CIR. SE DECISION MADE: 03-FEB-04 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURAD SILVER ACTIVE GEL BANDAGE BEIERSDORF AG 510(k) NO: K032462(TRADITIONAL) ATTN: DANIEL J DILLON PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 10-FEB-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURAD SILVER HEALING BANDAGE BEIERSDORF AG 510(k) NO: K032463(TRADITIONAL) ATTN: DANIEL J DILLON PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 10-FEB-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR BIO-DETEK, INC. 510(k) NO: K033771(TRADITIONAL) ATTN: ROBERT MORSE PHONE NO : 800-225-1310 525 NARRAGANSETT PARK DR. SE DECISION MADE: 27-FEB-04 PAWTUCKET, RI 02861-4323 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK HEMOSTASIS CONTROL BIO-RAD 510(k) NO: K040275(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 27-FEB-04 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) BIO-RAD LABORATORIES, INC. 510(k) NO: K033924(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 03-FEB-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED 510(k) NO: K033761(TRADITIONAL) ATTN: JOHN GREENBAUM PHONE NO : 954-680-0161 20310 SW 48TH STREET SE DECISION MADE: 04-FEB-04 FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITANIUM TOGGLE BUTTON(S) BIOMET MANUFACTURING, INC. 510(k) NO: K033838(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 13-FEB-04 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE BIOMET, INC. 510(k) NO: K033506(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 02-FEB-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT BIOPTRON AG 510(k) NO: K032216(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 04-FEB-04 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER BLACKSTONE MEDICAL, INC. 510(k) NO: K040034(SPECIAL) ATTN: DEAN CIPORKIN PHONE NO : 413-726-2513 90 BROOKSDALE DR. SE DECISION MADE: 11-FEB-04 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSET FRACTURE FIXATION SYSTEM BONUTTI RESEARCH, INC. 510(k) NO: K033717(TRADITIONAL) ATTN: PATRICK G BALSMANN PHONE NO : 217-342-3412 2600 SOUTH RANEY SE DECISION MADE: 25-FEB-04 P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA EFFINGHAM, IL 62401 DEVICE: COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 BOSTON SCIENTIFIC CORP. 510(k) NO: K040104(SPECIAL) ATTN: APRIL I MALMBORG PHONE NO : 408-895-3637 2710 ORCHARD PKWY. SE DECISION MADE: 18-FEB-04 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQ GUIDE WIRE BOSTON SCIENTIFIC CORP. 510(k) NO: K040140(SPECIAL) ATTN: ANNE V ROSSI PHONE NO : 763-494-2827 TWO SCIMED PLACE SE DECISION MADE: 12-FEB-04 M/S B220 510(k) SUMMARY AVAILABLE FROM FDA MAPLE GROVE, MN 55311 DEVICE: COBRA SURGICAL PROBE BOSTON SCIENTIFIC CORP. 510(k) NO: K040219(SPECIAL) ATTN: APRIL I MALMBORG PHONE NO : 408-895-3637 2710 ORCHARD PKWY. SE DECISION MADE: 24-FEB-04 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTORVISION CRANIAL/ENT BRAINLAB AG 510(k) NO: K023651(TRADITIONAL) ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680 AMMERTHALSTRASSE 8 SE DECISION MADE: 17-FEB-04 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. 510(k) NO: K033497(SPECIAL) ATTN: AYMEE R BERRY PHONE NO : 480-303-2752 PO BOX 1740 SE DECISION MADE: 04-FEB-04 1625 WEST 3RD STREET 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281-1740 DEVICE: BARD TIGERTAIL URETERAL CATHETER C.R. BARD, INC. 510(k) NO: K033719(TRADITIONAL) ATTN: FRANCES HARRISON PHONE NO : 770-784-6257 8195 INDUSTRIAL BLVD. SE DECISION MADE: 04-FEB-04 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD ATLAS PTA BALLOON DILATATION CATHETER C.R. BARD, INC. 510(k) NO: K040243(SPECIAL) ATTN: AYMEE R BERRY PHONE NO : 480-303-2752 1625 WEST 3RD ST. SE DECISION MADE: 13-FEB-04 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281-1740 DEVICE: C.T.M. POWER CHAIR, MODEL HS-1000 C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K040020(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 775-851-3804 1630 DUTCH RAVINE COURT SE DECISION MADE: 18-FEB-04 RENO, NV 89521 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QCA (VERSION 3.1) CELL ANALYSIS, INC. 510(k) NO: K031363(ABBREVIATED) ATTN: JOEL HERM PHONE NO : 847-275-5843 1801 MAPLE AVENUE SE DECISION MADE: 05-FEB-04 SUTIE 2319 510(k) SUMMARY AVAILABLE FROM FDA EVANSTON, IL 60202 DEVICE: CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB 510(k) NO: K033840(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 10-FEB-04 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHASE CARDIAC ANALYSIS SYSTEM CHASE MEDICAL, INC. 510(k) NO: K032531(TRADITIONAL) ATTN: DAVID M HERNON PHONE NO : 972-783-0644 1876 FIRMAN DR. SE DECISION MADE: 02-FEB-04 RICHARDSON, TX 75081 510(k) STATEMENT DEVICE: AQUIFY MULTI-PURPOSE SOLUTION CIBA VISION CORP. 510(k) NO: K033608(SPECIAL) ATTN: STEVEN DOWDLEY PHONE NO : 687-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 02-FEB-04 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS A CLINIQA CORPORATION 510(k) NO: K040091(TRADITIONAL) ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432 SOUTH MISSION RD. SE DECISION MADE: 23-FEB-04 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER COBE CARDIOVASCULAR, INC. 510(k) NO: K040184(SPECIAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6194 14401 WEST 65TH WAY SE DECISION MADE: 26-FEB-04 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS CODENT TECHNICAL INDUSTRY CO., LTD510(k) NO: K033213(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO.58, FU-CHUIN STREET SE DECISION MADE: 06-FEB-04 HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80 CODMAN & SHURTLEFF, INC. 510(k) NO: K033395(TRADITIONAL) ATTN: LIZ DOLAN PHONE NO : 508-828-3262 325 PARAMOUNT DR. SE DECISION MADE: 25-FEB-04 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESS-MATE BX-10 VITAL SIGN MONITOR COLIN MEDICAL INSTRUMENTS CORP. 510(k) NO: K032857(TRADITIONAL) ATTN: MARK RISON PHONE NO : 800-829-6427 5850 FARINON DR. SE DECISION MADE: 04-FEB-04 SAN ANTONIO, TX 78249 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING COLLAGEN MATRIX, INC. 510(k) NO: K040211(SPECIAL) ATTN: PEGGY HANSEN PHONE NO : 201-405-1477 509 COMMERCE ST. SE DECISION MADE: 27-FEB-04 FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIS PLASTIC SURGERY MATRIX COOK BIOTECH, INC. 510(k) NO: K034039(TRADITIONAL) ATTN: MARK BLEYER PHONE NO : 765-497-3355 3055 KENT AVE. SE DECISION MADE: 18-FEB-04 WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK FIVE LUMEN CENTRAL VENOUS CATHETER COOK, INC. 510(k) NO: K032274(TRADITIONAL) ATTN: JENNIFER J BOSLEY PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 26-FEB-04 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARCATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. 510(k) NO: K033622(SPECIAL) ATTN: KIM TOMPKINS PHONE NO : 408-866-3203 160 KNOWLES DR. SE DECISION MADE: 10-FEB-04 LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APOGEE ELITE CYNOSURE, INC. 510(k) NO: K034030(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 09-FEB-04 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0 DADE BEHRING, INC. 510(k) NO: K032706(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 2040 ENTERPRISE BLVD. SE DECISION MADE: 10-FEB-04 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DADE BEHRING, INC. 510(k) NO: K033713(TRADITIONAL) ATTN: ANDREA M TASKER PHONE NO : 302-631-9454 P.O. BOX 6101 BUILDING 500 SE DECISION MADE: 09-FEB-04 GLASGOW BUSINESS COMMUNITY 510(k) SUMMARY AVAILABLE FROM FDA NEWARK,, DE 19714 DEVICE: DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENS DADE BEHRING, INC. 510(k) NO: K033809(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 20-FEB-04 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVU DADE BEHRING, INC. 510(k) NO: K033940(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 2040 ENTERPRISE BLVD. SE DECISION MADE: 25-FEB-04 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIO MONITOR MODEL 0998-00-0600 DATASCOPE CORP. 510(k) NO: K032338(ABBREVIATED) ATTN: SUSAN E MANDY PHONE NO : 201-995-8025 800 MACARTHUR BLVD. SE DECISION MADE: 11-FEB-04 MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER LED DENTAL PRODUCTS OF USA, INC. 510(k) NO: K033697(TRADITIONAL) ATTN: GEORGE ECHEVERRI PHONE NO : 305-640-9894 1460 N.W. 107 AVE., SUITE G SE DECISION MADE: 27-FEB-04 MIAMI, FL 33174 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDEAL 1 ORTHODONTIC BRACKET ADHESIVE DENTSPLY INTL. 510(k) NO: K033703(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVENUE SE DECISION MADE: 06-FEB-04 P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17405-0872 DEVICE: ACE PROXIMAL HUMERAL NAIL SYSTEM DEPUY ACE 510(k) NO: K033806(TRADITIONAL) ATTN: RHONDA MYER PHONE NO : 574-371-4944 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 20-FEB-04 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM DEPUY ACE 510(k) NO: K033878(TRADITIONAL) ATTN: RHONDA MYER PHONE NO : 574-371-4944 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 20-FEB-04 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY SIGMA TIBIAL INSERTS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033272(TRADITIONAL) ATTN: CHERYL K HASTINGS PHONE NO : 574-372-7006 700 ORTHOPAEDIC DR. SE DECISION MADE: 05-FEB-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033382(TRADITIONAL) ATTN: TIFFANI D ROGERS PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 05-FEB-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: SMARTSET GHV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033563(TRADITIONAL) ATTN: TIFFANI D ROGERS PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 05-FEB-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEPUY SIGMA XLK TIBIAL INSERTS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K040166(TRADITIONAL) ATTN: CHERYL K HASTINGS PHONE NO : 574-372-7006 700 ORTHOPAEDIC DR. SE DECISION MADE: 23-FEB-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: MODIFICATION TO DIADEXUS PLAC TEST DIADEXUS, INC. 510(k) NO: K040101(SPECIAL) ATTN: ROBERT L WOLFERT PHONE NO : 650-246-6430 343 OYSTER POINT BLVD. SE DECISION MADE: 05-FEB-04 SOUTH SAN FRANCISCO, CA 94080 510(k) STATEMENT DEVICE: LIAISON 25 OH VITAMIN D DIASORIN, INC. 510(k) NO: K032844(TRADITIONAL) ATTN: DAVID IKEDA PHONE NO : 651-351-5592 1951 NORTHWESTERN AVE. SE DECISION MADE: 12-FEB-04 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082 DEVICE: LIAISON N-TACT PTH DIASORIN, INC. 510(k) NO: K033426(TRADITIONAL) ATTN: DAVID M IKEDA PHONE NO : 651-351-5592 1951 NORTHWESTERN AVE. SE DECISION MADE: 12-FEB-04 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082 DEVICE: DORC VITRECTOMY LENSES, MODEL 1284 SERIES DUTCH OPHTHALMIC RESEARCH CENTER (510(k) NO: K033950(TRADITIONAL) ATTN: FRAN CARLETON PHONE NO : 603-642-8468 ONE LITTLE RIVER ROAD SE DECISION MADE: 20-FEB-04 KINGSTON, NH 03848 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY EASTMAN KODAK COMPANY 510(k) NO: K033821(TRADITIONAL) ATTN: STEPHEN SLAVENS PHONE NO : 651-393-1395 1 IMATION WAY SE DECISION MADE: 20-FEB-04 OAKDALE, MN 55128-3414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANDMAN SD20 AMPLIFIER EB NEURO, S.P.A. 510(k) NO: K040113(SPECIAL) ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916 7992 CASTLEWAY DR. SE DECISION MADE: 18-FEB-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLOR LCD DISPLAY, MODEL RADIFORCE R22 EIZO NANAO CORPORATION 510(k) NO: K033466(SPECIAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO-CHO SE DECISION MADE: 20-FEB-04 MATTO-SHI 510(k) STATEMENT ISHIKAWA-KEN, JAPAN 924-8566 DEVICE: LEKSELL SURGIPLAN WITH IMAGEMERGE ELEKTA INSTRUMENT AB 510(k) NO: K033340(SPECIAL) ATTN: PETER LOWENDAHL PHONE NO : 011 468 58725400 BIRGER JARLSGATAN 53 SE DECISION MADE: 12-FEB-04 PO BOX 7593 510(k) STATEMENT STOCKHOLM, SWEDEN SE-103 93 DEVICE: TITANIUM MESH SYSTEM ENCORE MEDICAL, L.P. 510(k) NO: K032371(TRADITIONAL) ATTN: KIMBERLY L PRUITT PHONE NO : 512-834-6291 9800 METRIC BLVD. SE DECISION MADE: 12-FEB-04 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER ENDOBIONICS, INC. 510(k) NO: K040139(TRADITIONAL) ATTN: KIRK P SEWARD PHONE NO : 510-614-4555 3077 TEAGARDEN STREET SE DECISION MADE: 18-FEB-04 SAN LEANDRO, CA 94577-5720 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EP-4 CLINICAL STIMULATOR EP MEDSYSTEMS 510(k) NO: K040207(SPECIAL) ATTN: JAMES E KUHN PHONE NO : 856-753-8533 COOPER RUN EXECUTIVE PARK SE DECISION MADE: 27-FEB-04 575 RT. 73 NORTH, BLDG. D 510(k) STATEMENT WEST BERLIN, NJ 08091 DEVICE: EPICOR MEDICAL ULTRAMAZE ABLATION SYSTEM EPICOR MEDICAL, INC. 510(k) NO: K022894(TRADITIONAL) ATTN: KATHI GUERRANT PHONE NO : 408-733-6500 240 SANTA ANA COURT SE DECISION MADE: 26-FEB-04 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOTOME EX HAND HELD SYSTEM ETHICON ENDO-SURGERY, INC. 510(k) NO: K033700(TRADITIONAL) ATTN: CAROL SPRINKLE PHONE NO : 513-337-3792 4545 CREEK RD. SE DECISION MADE: 20-FEB-04 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED ST ETHICON ENDO-SURGERY, INC. 510(k) NO: K040038(TRADITIONAL) ATTN: KATIE FORDYCE PHONE NO : 513-337-8995 4545 CREEK RD. SE DECISION MADE: 04-FEB-04 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPACS ETRAUMA.COM CORP. 510(k) NO: K033825(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 02-FEB-04 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH RESORBABLE BONE PASTE EXACTECH, INC. 510(k) NO: K020078(TRADITIONAL) ATTN: STEVE LIN PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 27-FEB-04 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILI EXACTECH, INC. 510(k) NO: K033883(SPECIAL) ATTN: GARY MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 13-FEB-04 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXSYM CORTISOL ASSAY FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K033731(TRADITIONAL) ATTN: KIMBERLY PETERSON PHONE NO : 610-240-3828 201 GREAT VALLEY PKWY. SE DECISION MADE: 20-FEB-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRADIA GUM GC AMERICA, INC. 510(k) NO: K033808(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 02-FEB-04 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 GE MED. SYSTEMS ULTRASOUND & PRIM.510(k) NO: K040251(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 4855 WEST ELECTRIC AVE. SE DECISION MADE: 20-FEB-04 P.O. BOX 414 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53219 DEVICE: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. 510(k) NO: K040248(SPECIAL) ATTN: SHOSH FRIEDMAN PHONE NO : 972 4 9097784 13 HAYETZIRA STREET SE DECISION MADE: 17-FEB-04 NEW INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM, ISRAEL 20692 DEVICE: GOLDWAY UT4000A VITAL SIGNS MONITOR GOLDWAY (US), INC. 510(k) NO: K033988(TRADITIONAL) ATTN: YINGCHAO XIAO PHONE NO : 626-799-0998 2600 MISSION STREET SE DECISION MADE: 25-FEB-04 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA SAN MARINO, CA 91108 DEVICE: HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM GYRUS ENT L.L.C. 510(k) NO: K033089(TRADITIONAL) ATTN: GREGORY SREDIN PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 05-FEB-04 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEGIS PIT & FISSURE SEALANT WITH ACP HARRY J. BOSWORTH CO. 510(k) NO: K033751(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 05-FEB-04 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: HELICA "TC" LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE HELICA INSTRUMENTS, LTD 510(k) NO: K032969(TRADITIONAL) ATTN: JOHN B WEBB PHONE NO : 949-673-0640 1020 WEST BAY AVE. SE DECISION MADE: 04-FEB-04 NEWPORT BEACH, CA 92661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRAL STATION, VERSION 3.3H HOMMED LLC. 510(k) NO: K040032(TRADITIONAL) ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111 2018 NORTH DURHAM DR. SE DECISION MADE: 27-FEB-04 HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE HONG HUANG TANG INDUSTRIAL CO., LT510(k) NO: K034060(TRADITIONAL) ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING ROAD SE DECISION MADE: 06-FEB-04 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: EIUS UNICOMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K033769(SPECIAL) ATTN: DENISE DUCHENE PHONE NO : 201-831-5612 325 CORPORATE DR. SE DECISION MADE: 13-FEB-04 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER SPINE OASYS SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K032394(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 59 ROUTE 17 SE DECISION MADE: 20-FEB-04 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANSSON PIN SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K033968(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 20-FEB-04 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLAR RADIUS PLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K033756(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 06-FEB-04 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN IBL GMBH 510(k) NO: K033786(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570-620-0198 150 CHERRY LANE RD. SE DECISION MADE: 27-FEB-04 EAST STROUDSBURG, PA 18301 510(k) STATEMENT DEVICE: INFRARED SCIENCES BREASTSCAN IR SYSTEM INFRARED SCIENCES CORP. 510(k) NO: K032350(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 20-FEB-04 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL FACTOR VIII DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. 510(k) NO: K034007(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 13-FEB-04 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K040201(SPECIAL) ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 26-FEB-04 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSTELL MENTOR RFA INTEGRATION DIAGNOSTICS LTD 510(k) NO: K033689(TRADITIONAL) ATTN: TRISH LANDRY PHONE NO : 202-546-1262 719 A STREET NE SE DECISION MADE: 26-FEB-04 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTEP-ASSR, MODEL M811007 INTELLIGENT HEARING SYSTEMS 510(k) NO: K031051(TRADITIONAL) ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102 7356 S.W. 48 ST. SE DECISION MADE: 20-FEB-04 MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM INTERLAB S.R.L. 510(k) NO: K032862(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570-620-0198 150 CHERRY LANE RD. SE DECISION MADE: 03-FEB-04 EAST STROUDSBURG, PA 18301-8804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILE COMPACT DIGITAL CARDIAC CAMERA IS2 RESEARCH, INC. 510(k) NO: K040057(SPECIAL) ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755 20 GURDWARA RD., UNITS 3-10 SE DECISION MADE: 02-FEB-04 OTTAWA, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL TOP ANCHOR SYSTEM SCREWS JEIL MEDICAL CORPORATION 510(k) NO: K033767(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 24-FEB-04 DEERFILED, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OP KANAM LATEX INDUSTRIES PVT. LTD. 510(k) NO: K033564(TRADITIONAL) ATTN: RAVI ABRAHAM PHONE NO : 91 481 2300343 OPPOOTTIL BUILDING SE DECISION MADE: 24-FEB-04 P.O. BOX #28 K.K.ROAD 510(k) STATEMENT KOTTAYAM, KERALA, INDIA 686001 DEVICE: TRANSVAGINAL ENDOSCOPY SET KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K033728(TRADITIONAL) ATTN: YVONNE FERNANDEZ PHONE NO : 310-348-4226 600 CORPORATE POINTE SE DECISION MADE: 27-FEB-04 5TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CULVER CITY, CA 90230-7600 DEVICE: PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER KENDALL 510(k) NO: K033676(TRADITIONAL) ATTN: JAMES WELSH PHONE NO : 508-261-8532 15 HAMPSHIRE ST. SE DECISION MADE: 20-FEB-04 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM KLS-MARTIN L.P. 510(k) NO: K034027(TRADITIONAL) ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746 11239-1 ST. JOHNS INDUSTRIAL SE DECISION MADE: 27-FEB-04 PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: ECHO SOUNDER EX-101EX 8 MHZ KOVEN TECHNOLOGY, INC. 510(k) NO: K031931(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 13-FEB-04 HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABONE MICRO-PLATE COTININE EIA LABONE, INC. 510(k) NO: K033601(TRADITIONAL) ATTN: LIUMING YU PHONE NO : 913-895-2308 10101 RENNER BLVD. SE DECISION MADE: 10-FEB-04 LENEXA, KS 66219 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 10 LAC MAC, LTD. 510(k) NO: K032631(TRADITIONAL) ATTN: JEFRREY O STULL PHONE NO : 512-288-8272 10907 WAREHAM COURT SE DECISION MADE: 05-FEB-04 AUSTIN, TX 78739 510(k) STATEMENT DEVICE: LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM LARSEN & TOUBRO LIMITED 510(k) NO: K040409(TRADITIONAL) ATTN: A.B. DESHPANDE PHONE NO : 011 918 212402561 KIADB INDUSTRIAL AREA SE DECISION MADE: 27-FEB-04 HEBBAL, HOTTAGALLI 510(k) SUMMARY AVAILABLE FROM FDA MYSORE, KARNATAKA, INDIA 570 018 THIRD PARTY REVIEW DEVICE: SKINTACT ECG ELECTRODE LEONHARD LANG GMBH 510(k) NO: K040249(SPECIAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 24-FEB-04 STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVIA PHOTOTHERAPY SYSTEM LERNER MEDICAL DEVICES, INC. 510(k) NO: K040062(TRADITIONAL) ATTN: ZAFIRIOS GOURGOULIATOS PHONE NO : 310-914-0091 1545 SAWTELLE BLVD., SUITE 36 SE DECISION MADE: 13-FEB-04 LOS ANGELES, CA 90025 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 LIGHT AGE, INC. 510(k) NO: K033259(TRADITIONAL) ATTN: THOMAS HAUCK PHONE NO : 732-563-0600 500 APGAR DRIVE SE DECISION MADE: 25-FEB-04 SOMERSET, NJ 08873-1150 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINVATEC 10K IRRIGATION SYSTEM LINVATEC CORP. 510(k) NO: K033573(TRADITIONAL) ATTN: LAURA D KREJCI PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 11-FEB-04 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 MAINE STANDARDS CO. 510(k) NO: K033879(TRADITIONAL) ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300 765 ROOSEVELT TRAIL SE DECISION MADE: 27-FEB-04 SUITE 9A 510(k) SUMMARY AVAILABLE FROM FDA WINDHAM, ME 04062-5365 DEVICE: MANOA BREAST BIOPSY SYSTEM MANOA MEDICAL, INC. 510(k) NO: K033205(TRADITIONAL) ATTN: ROBERTA LEE PHONE NO : 650-759-5520 1017 EL CAMINO SE DECISION MADE: 18-FEB-04 # 361 510(k) SUMMARY AVAILABLE FROM FDA REDWOOD CITY, CA 94063 DEVICE: SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E MAQUET CRITICAL CARE AB 510(k) NO: K040221(SPECIAL) ATTN: JAMIE YIEH PHONE NO : 908-227-8807 186 WOOD AVENUE SOUTH SE DECISION MADE: 20-FEB-04 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR MASIMO CORP. 510(k) NO: K032551(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 19-FEB-04 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V MASIMO CORP. 510(k) NO: K033296(TRADITIONAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 19-FEB-04 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE MASIMO CORP. 510(k) NO: K040214(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 25-FEB-04 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K040176(TRADITIONAL) ATTN: PRISCILLA WEE PHONE NO : 603 339 29888 LOT 6070, JALAN HAJI ABDUL SE DECISION MADE: 24-FEB-04 MANAN, 6TH MILES OFF JALAN 510(k) STATEMENT MERU, KLANG, SELANGOR, MALAYSIA 41050 DEVICE: PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 MED-TEC,INC. 510(k) NO: K034054(TRADITIONAL) ATTN: DONALD F RIIBE PHONE NO : 712-737-8688 1401 8TH ST. S.E. SE DECISION MADE: 20-FEB-04 P.O. BOX 320 510(k) STATEMENT ORANGE CITY, IA 51041 DEVICE: MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER MEDAMICUS, INC. 510(k) NO: K040150(SPECIAL) ATTN: KARYL HASKELL PHONE NO : 763-577-2257 15301 HWY. 55 WEST SE DECISION MADE: 18-FEB-04 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARNISHAMERICA MEDICAL PRODUCTS LABORATORIES, INC510(k) NO: K040098(TRADITIONAL) ATTN: ROBERT J MALERMAN PHONE NO : 215-677-2700 9990 GLOBAL RD. SE DECISION MADE: 04-FEB-04 PHILADELPHIA, PA 19115 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EARLOOP PROCEDURE MASK MEDIPACK MEDICAL PACKAGING MFG.CO.510(k) NO: K034015(TRADITIONAL) ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100 1202 S. RTE 31 SE DECISION MADE: 20-FEB-04 MCHENRY, IL 60050 510(k) STATEMENT DEVICE: MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4 MEDLINE INDUSTRIES, INC. 510(k) NO: K032446(TRADITIONAL) ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759 ONE MEDLINE PL. SE DECISION MADE: 12-FEB-04 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: MEDLINE STRIDER MIDI 3 MEDLINE INDUSTRIES, INC. 510(k) NO: K040097(TRADITIONAL) ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759 ONE MEDLINE PL. SE DECISION MADE: 13-FEB-04 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K040167(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 18-FEB-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K040072(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 12-FEB-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVOY PATIENT MONITOR MENNEN MEDICAL, INC. 510(k) NO: K030722(TRADITIONAL) ATTN: ASHER KASSEL PHONE NO : 972 8 9323311 P.O. BOX 102 SE DECISION MADE: 26-FEB-04 REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONO MERCURY MEDICAL 510(k) NO: K032593(TRADITIONAL) ATTN: WAYNE GLOVER PHONE NO : 800-237-6418 11300 49TH ST. NORTH SE DECISION MADE: 03-FEB-04 CLEARWATER, FL 33762-4800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VICEROY INFLATION DEVICE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K040138(TRADITIONAL) ATTN: JOHN NICHOLSON PHONE NO : 801-208-4405 1600 WEST MERIT PKWY. SE DECISION MADE: 13-FEB-04 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONDUCTIVITY/TDS CALIBRATOR SOLUTION MESA LABORATORIES, INC. 510(k) NO: K033330(TRADITIONAL) ATTN: TODD ROMERO PHONE NO : 303-987-8000 12100 WEST 6TH AVE. SE DECISION MADE: 27-FEB-04 LAKEWOOD, CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K033828(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 914-667-3999 521 HOMESTEAD AVE. SE DECISION MADE: 02-FEB-04 MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 MICRO THERAPEUTICS, INC. 510(k) NO: K034036(TRADITIONAL) ATTN: BILL HYATT PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 13-FEB-04 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K033820(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-FEB-04 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS MODIFIED MICROCOIL SYSTEM, "CERECYTE" MICRUS CORP. 510(k) NO: K033813(TRADITIONAL) ATTN: MARGARET WEBBER PHONE NO : 408-830-5900 610 PALOMAR AVENUE SE DECISION MADE: 04-FEB-04 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINXRAY, MODEL HF120/60H POWERPLUS MINXRAY, INC. 510(k) NO: K040046(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 02-FEB-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSSMED DUAL INTERMITTENT ASPIRATOR MOSS MEDICAL PRODUCTS 510(k) NO: K031492(TRADITIONAL) ATTN: GERALD MOSS PHONE NO : 516-674-0904 4049 NY 150 SE DECISION MADE: 05-FEB-04 WEST SAND LAKE, NY 12196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 N-DIA, INC. 510(k) NO: K030849(TRADITIONAL) ATTN: MICHAEL FRIEDMAN PHONE NO : 212-253-1310 30 E. 20TH ST., STE. 501 SE DECISION MADE: 02-FEB-04 NEW YORK, NY 10003 510(k) STATEMENT DEVICE: CREATION NM DIAGNOSTIC CATHETERS NEICH MEDICAL (SHENZHEN) COMPANY L510(k) NO: K032888(TRADITIONAL) ATTN: RAYMOND LIN PHONE NO : 867 758 3580181 1 JINKUI ROAD, FUTIAN FREE SE DECISION MADE: 24-FEB-04 TRADE ZONE 510(k) STATEMENT SHENZHEN, GUANGDONG P.R.O.C., CHINA 518038 DEVICE: SUPRAFLOW CONSOLE NEOMEDIX CORP. 510(k) NO: K040239(TRADITIONAL) ATTN: SOHEILA MIRHASHEMI PHONE NO : 949-249-1996 27452 CALLE ARROYO SE DECISION MADE: 17-FEB-04 SAN JUAN CAPISTRANO, CA 92675-2748510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K040309(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 24-FEB-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEETH IN AN HOUR - ARK IMPLANT CONCEPT NOBEL BIOCARE AB 510(k) NO: K030685(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 06-FEB-04 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCEARA COPINGS AND PONTIC NOBEL BIOCARE AB 510(k) NO: K032562(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22725 SAVI RANCH PKWY. SE DECISION MADE: 06-FEB-04 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 NOBEL BIOCARE USA, INC. 510(k) NO: K033724(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 23-FEB-04 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAD (EPITURE EASYTOUCH), MODEL LAD-08 NORWOOD ABBEY , LTD. 510(k) NO: K033962(SPECIAL) ATTN: PAUL CLARK PHONE NO : 613 978 27308 63 WELLS RD. SE DECISION MADE: 20-FEB-04 CHELSEA HGTS., VICTORIA, AUSTRALIA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVOSCI READY SYSTEM, MODEL RS-200 NOVOSCI CORP. 510(k) NO: K033270(TRADITIONAL) ATTN: LEANN LATHAM PHONE NO : 281-363-4949 2828 NORTH CRESCENT RIDGE DR. SE DECISION MADE: 13-FEB-04 THE WOODLANDS, TX 77381-3902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMULIX EVOLUTION NUCLETRON CORPORATION 510(k) NO: K033470(SPECIAL) ATTN: LISA DIMMICK PHONE NO : 410-312-4100 8671 ROBERT FULTON DR. SE DECISION MADE: 04-FEB-04 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907 OMRON HEALTHCARE, INC. 510(k) NO: K032305(TRADITIONAL) ATTN: IWAO KOJIMA PHONE NO : 847-680-6200 300 LAKEVIEW PKWY. SE DECISION MADE: 11-FEB-04 VERNON HILLS, IL 60061 510(k) STATEMENT DEVICE: IR FOREHEAD THERMOMETER, MODEL HV-T36 ORIENTAL INSPIRATION LTD 510(k) NO: K032612(ABBREVIATED) ATTN: JAY MANSOUR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 19-FEB-04 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS OSSEUS, LLC 510(k) NO: K040199(SPECIAL) ATTN: SHAWN T HUXEL PHONE NO : 908-997-0127 3131 PRINCETON PIKE SE DECISION MADE: 20-FEB-04 BLDG. 5, SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCEVILLE, NJ 08648 DEVICE: INTEGRIS 3D-RA, RELEASE 4.2 PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K040254(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 19-FEB-04 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 THIRD PARTY REVIEW DEVICE: BRAIN PERFUSION OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K033677(TRADITIONAL) ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528 595 MINER ROAD SE DECISION MADE: 20-FEB-04 HIGHLAND HTS., OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1 PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K032979(SPECIAL) ATTN: EGON PFEIL PHONE NO : 497 031 4631926 HEWLETT PACKARD STR. 2 SE DECISION MADE: 20-FEB-04 BOBLINGEN, GERMANY D71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY SPINE ARRAY COIL PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K033662(TRADITIONAL) ATTN: DUANE C PRASCHAN PHONE NO : 440-483-5743 595 MINER RD. SE DECISION MADE: 02-FEB-04 HIGHLAND HGTS., OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREME PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K033715(SPECIAL) ATTN: DAVID OSBORN PHONE NO : 978-659-3178 3000 MINUTEMAN RD. SE DECISION MADE: 13-FEB-04 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QLAB QUANTIFICATION SOFTWARE PHILIPS ULTRASOUND 510(k) NO: K040227(TRADITIONAL) ATTN: STEVE SINGLAR PHONE NO : 978-659-1201 3000 MINUTEMAN RD. SE DECISION MADE: 17-FEB-04 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CEREDEPTH SEDATION MONITOR WITH FRONTAL PSI PHYSIOMETRIX, INC. 510(k) NO: K033999(SPECIAL) ATTN: DAWN E FRAZER PHONE NO : 978-670-2422 FIVE BILLERICA PARK, SE DECISION MADE: 06-FEB-04 101 BILLERICA AVE. 510(k) SUMMARY AVAILABLE FROM FDA NORTH BILLERICA, MA 01862 DEVICE: POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMIS POLYMEDCO, INC. 510(k) NO: K033706(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 425-814-1514 510 FURNACE DOCK RD. SE DECISION MADE: 04-FEB-04 CORTLANDT MANOR, NY 10567 510(k) STATEMENT DEVICE: PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR PORTEX LTD. 510(k) NO: K040014(TRADITIONAL) ATTN: BARRY SMITH PHONE NO : 00 440 1303236768 MILITARY ROAD SE DECISION MADE: 13-FEB-04 HYTHE, KENT, UNITED KINGDOM CT21 6510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K040024(SPECIAL) ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151 110 UNION SQUARE DR. SE DECISION MADE: 04-FEB-04 NEW HOPE PA, PA 18938 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYST PRECISION SURGERY LIMITED 510(k) NO: K032815(TRADITIONAL) ATTN: KAREN E WARDEN PHONE NO : 440-729-8457 8202 SHERMAN ROAD SE DECISION MADE: 12-FEB-04 CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ULTRA SYSTEM SP PROMEDICA, INC. 510(k) NO: K032813(TRADITIONAL) ATTN: RICHARD BLOOM PHONE NO : 813-889-9250 114 DOUGLAS RD EAST SE DECISION MADE: 13-FEB-04 OLDSMAR, FL 34677 510(k) STATEMENT DEVICE: MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AF PROXIMA THERAPEUTICS, INC. 510(k) NO: K032067(TRADITIONAL) ATTN: MARTINE D SCHNEIDER PHONE NO : 770-753-4848 2555 MARCONI DRIVE, SUITE 220 SE DECISION MADE: 10-FEB-04 ALPHARETTA, GA 30005-2066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXA PT. MEDISAFE TECHNOLOGIES 510(k) NO: K033086(TRADITIONAL) ATTN: ANIL TANEJA PHONE NO : 62 61 4515834 JL. KAPT. PATTIMURA NO. 23 SE DECISION MADE: 26-FEB-04 MEDAN, NORTH SUMATRA, INDONESIA 20510(k) STATEMENT DEVICE: PHOSPHOLIN ES AND CALCIUM CHLORIDE R2 DIAGNOSTICS, INC. 510(k) NO: K033471(TRADITIONAL) ATTN: PEGGY S CARTER PHONE NO : 574-288-4377 412 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 04-FEB-04 SOUTH BEND, IN 46601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX URIC ACID RANDOX LABORATORIES, LTD. 510(k) NO: K033278(TRADITIONAL) ATTN: LYNNE HAMILTON PHONE NO : 44 289 4422413 55 DIAMOND RD. SE DECISION MADE: 27-FEB-04 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY REMEL INC 510(k) NO: K033479(TRADITIONAL) ATTN: DAVID TEICHER PHONE NO : 763-712-2347 14000 UNITY STREET NW SE DECISION MADE: 26-FEB-04 RAMSEY, MN 55303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C2 NASAL MASK RESPIRONICS, INC. 510(k) NO: K033759(TRADITIONAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 19-FEB-04 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRONICS CUSTOM I ORAL APPLIANCE RESPIRONICS, INC. 510(k) NO: K033822(SPECIAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 06-FEB-04 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRONICS CUSTOM II ORAL APPLIANCE RESPIRONICS, INC. 510(k) NO: K033823(SPECIAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 06-FEB-04 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT REX MEDICAL 510(k) NO: K040252(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SE DECISION MADE: 26-FEB-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: ELECSYS C-PEPTIDE CALSET ROCHE DIAGNOSTICS CORP. 510(k) NO: K033873(TRADITIONAL) ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 13-FEB-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS C-PEPTIDE CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K040157(TRADITIONAL) ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 25-FEB-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K033656(TRADITIONAL) ATTN: LIGIA DELACRUZ PHONE NO : 442 083 224200 49-53 YORK ST. SE DECISION MADE: 02-FEB-04 TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 SAUTER AG 510(k) NO: K033538(SPECIAL) ATTN: HANS STADLER PHONE NO : ZELGSTRASSE 8 SE DECISION MADE: 02-FEB-04 SULGEN TG, SWITZERLAND CH-8583 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION SENSORMEDICS CORP. 510(k) NO: K031745(TRADITIONAL) ATTN: EARL W DRAPER PHONE NO : 714-283-2228 22705 SAVI RANCH PKWY. SE DECISION MADE: 13-FEB-04 YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A SERADYN INC. 510(k) NO: K033674(TRADITIONAL) ATTN: LES PADILLA PHONE NO : 317-610-3823 7998 GEORGETOWN RD. SE DECISION MADE: 09-FEB-04 SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46268 DEVICE: DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE SHIMADZU CORP. 510(k) NO: K032443(ABBREVIATED) ATTN: TAKESHI OZAKI PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 20-FEB-04 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN SHOFU DENTAL CORP. 510(k) NO: K032416(TRADITIONAL) ATTN: ROBERT NOBLE PHONE NO : 760-736-3277 1225 STONE DR. SE DECISION MADE: 05-FEB-04 SAN MARCOS, CA 92069-4059 510(k) STATEMENT DEVICE: ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K033650(TRADITIONAL) ATTN: ISKRA MRAKOVIC PHONE NO : 650-694-5004 1230 SHOREBIRD WAY SE DECISION MADE: 24-FEB-04 MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIREMOBILE C06 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K040066(SPECIAL) ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769 51 VALLEY STREAM PKWY. SE DECISION MADE: 12-FEB-04 J-15 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: SINON POWER WHEELCHAIR, SN-W401 SINON CORPORATION 510(k) NO: K040319(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 20-FEB-04 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIROAIR L AIR SCALER SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K033812(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 23-FEB-04 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 SMITH & NEPHEW, INC. 510(k) NO: K033981(TRADITIONAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1494 150 MINUTEMAN RD. SE DECISION MADE: 25-FEB-04 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIGEN INTERTAN SMITH & NEPHEW, INC. 510(k) NO: K040212(SPECIAL) ATTN: KIM KELLY PHONE NO : 901-399-6566 1450 E. BROOKS RD. SE DECISION MADE: 20-FEB-04 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB SOPHYSA SA 510(k) NO: K031097(TRADITIONAL) ATTN: JACQUELINE E MASSE PHONE NO : 781-239-8108 70 WALNUT ST. SE DECISION MADE: 26-FEB-04 WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 51 SPECTRANETICS CORP. 510(k) NO: K033678(TRADITIONAL) ATTN: MICHAEL J RYAN PHONE NO : 719-633-8333 96 TALAMINE CT. SE DECISION MADE: 23-FEB-04 COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL CONCEPTS INC. CADENCE AND TRAXIS SPINAL CONCEPTS, INC. 510(k) NO: K033517(SPECIAL) ATTN: LISA PETERSON PHONE NO : 512-533-1080 5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 18-FEB-04 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLORADO MICRODISSECTION NEEDLE STRYKER CORP. 510(k) NO: K033232(TRADITIONAL) ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226 4100 EAST MILHAM AVE. SE DECISION MADE: 25-FEB-04 KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BILEVEL CPAP, MODEL 9055 SERIES SUNRISE MEDICAL 510(k) NO: K032056(TRADITIONAL) ATTN: STEPHEN KREPELKA PHONE NO : 814-443-7671 100 DEVILBISS DR. SE DECISION MADE: 20-FEB-04 SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSTAT PVA FOAM EMBOLIZATION PARTICLES SURGICA CORP. 510(k) NO: K032619(SPECIAL) ATTN: LOU MATSON PHONE NO : 916-933-5056 5090 ROBERT J. MATHEWS PKWY. SE DECISION MADE: 13-FEB-04 #4 510(k) SUMMARY AVAILABLE FROM FDA EL DORADO HILLS, CA 95762 DEVICE: ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K033777(TRADITIONAL) ATTN: TITO ALDAPE PHONE NO : 775-746-6600 PO BOX 32000 SE DECISION MADE: 05-FEB-04 RENO, NV 89533-2000 510(k) STATEMENT DEVICE: SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SYNTHES (USA) 510(k) NO: K033618(TRADITIONAL) ATTN: BONNIE SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 05-FEB-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES SYNTHES (USA) 510(k) NO: K033805(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 20-FEB-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM SYNTHES (USA) 510(k) NO: K033844(SPECIAL) ATTN: SUSAN LEWANDOWSKI PHONE NO : 484-356-9614 1230 WILSON DRIVE SE DECISION MADE: 05-FEB-04 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) CRANIOFACIAL PLATES SYNTHES (USA) 510(k) NO: K040272(SPECIAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 23-FEB-04 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYSMEX POCH-100I SYSMEX AMERICA, INC. 510(k) NO: K032677(TRADITIONAL) ATTN: CHRIS STUKEL PHONE NO : 847-996-4523 ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 11-FEB-04 MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIOX CARDIOTOMY RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K033800(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL RD. SE DECISION MADE: 10-FEB-04 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM THEKEN SURGICAL,LLC 510(k) NO: K032064(TRADITIONAL) ATTN: TONY PERRY PHONE NO : 330-773-7677 283 E WATERLOO RD. SE DECISION MADE: 20-FEB-04 AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAGE THERMACOOL SYSTEM THERMAGE, INC. 510(k) NO: K033942(TRADITIONAL) ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116 4058 POINT EDEN WAY SE DECISION MADE: 04-FEB-04 HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316 TOTOKU ELECTRIC CO., LTD 510(k) NO: K032555(TRADITIONAL) ATTN: MIKIO HASEGAWA PHONE NO : 011 812 268345484 300 OYA , UEDA-SHI, SE DECISION MADE: 26-FEB-04 NAGANO-KEN, JAPAN 386-0192 510(k) STATEMENT DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K033522(TRADITIONAL) ATTN: CINDY KNAPP PHONE NO : 800-871-8909 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 03-FEB-04 CLEVELAND, OH 44131 510(k) STATEMENT DEVICE: TRIMED RADIAL BULLET TRI-MED, INC. 510(k) NO: K030877(TRADITIONAL) ATTN: ROBERT J MEDOFF PHONE NO : 808-261-4658 159 KU'UKAMA ST. SE DECISION MADE: 05-FEB-04 KAILUA,, HI 96734 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STV PRO 2 TROPHY RADIOLOGIE 510(k) NO: K033419(TRADITIONAL) ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 33 1 64808500 4 RUE F. PELLOUTIER SE DECISION MADE: 02-FEB-04 CROISSY-BEAUBOURG 510(k) STATEMENT MARNE LA VALLEE CEDEX 2, FRANCE 77437 DEVICE: TROPHYPAN AND TROPHYPAN C TROPHY RADIOLOGIE 510(k) NO: K033690(TRADITIONAL) ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 33 1 64808500 4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 20-FEB-04 BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA MARNE LA VALLEE CEDEX 2, FRANCE 77437 DEVICE: ORTHODONTIC COMPOSITE BRACKET SYSTEM ULTRADENT PRODUCTS, INC. 510(k) NO: K032625(TRADITIONAL) ATTN: PETER ALLRED PHONE NO : 800-552-5512 505 WEST 10200 SOUTH SE DECISION MADE: 26-FEB-04 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 UNITED MEDICAL SYSTEMS, INC. 510(k) NO: K032958(TRADITIONAL) ATTN: JEFFREY K SHAPIRO PHONE NO : 202-637-5775 555 THIRTEENTH STREET, NW SE DECISION MADE: 17-FEB-04 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF UNITED RADIOLOGY SYSTEMS, INC. 510(k) NO: K032628(TRADITIONAL) ATTN: JOHN W LEE PHONE NO : 847-291-0999 151 SOUTH PFINGSTEN RD. SE DECISION MADE: 02-FEB-04 UNIT T 510(k) STATEMENT DEERFIELD, IL 60015 DEVICE: HEARTRAK SMART AT/HEARTRAK SMART2 UNIVERSAL MEDICAL, INC. 510(k) NO: K033451(SPECIAL) ATTN: DOUGLAS M LURIO PHONE NO : 215-665-9300 ONE COMMERCE SQUARE SE DECISION MADE: 05-FEB-04 2005 MARKET STREET, SUITE 2340 510(k) SUMMARY AVAILABLE FROM FDA PHILADELPHIA, PA 19103 DEVICE: ON-BOARD IMAGER DEVICE VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K040192(SPECIAL) ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY M/S H-055 SE DECISION MADE: 27-FEB-04 PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCON POLARIS GUIDING CATHETER VASCON LLC 510(k) NO: K033633(TRADITIONAL) ATTN: STEPHEN F VADAS PHONE NO : 305-477-2406 9344 NW 13 STREET SE DECISION MADE: 18-FEB-04 MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSTAT, MODELS 09-0014-01 AND 09-0014-02 VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K032125(TRADITIONAL) ATTN: KATHLEEN ROBERTS PHONE NO : 949-488-8700 32236 PASEO ADELANTO, STE. E SE DECISION MADE: 09-FEB-04 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT VASCULAR SOLUTIONS, INC. 510(k) NO: K033721(TRADITIONAL) ATTN: SARA L COON PHONE NO : 763-656-4399 6464 SYCAMORE COURT SE DECISION MADE: 13-FEB-04 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RAD VASCULAR SOLUTIONS, INC. 510(k) NO: K040118(SPECIAL) ATTN: GREGORY W SACHS PHONE NO : 763-656-4210 6464 SYCAMORE COURT NORTH SE DECISION MADE: 12-FEB-04 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELSOFT PLUS ERS VASCUTEK LTD. 510(k) NO: K034010(TRADITIONAL) ATTN: STEVEN ARICK PHONE NO : 734-663-4145 6200 JACKSON RD. SE DECISION MADE: 19-FEB-04 ANN ARBOR, MI 48103-9300 510(k) STATEMENT DEVICE: VERTEBRON PSS PEDICLE SCREW SYSTEM VERTEBRON, INC. 510(k) NO: K033352(TRADITIONAL) ATTN: BRUCE KHALILI PHONE NO : 203-380-9340 136 ALBERT AVENUE SE DECISION MADE: 25-FEB-04 STRATFORD, CT 06614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT VISTAKON 510(k) NO: K033969(TRADITIONAL) ATTN: ANNETTE M HILLRING PHONE NO : 904-443-1808 7500 CENTURION PKWY. SE DECISION MADE: 04-FEB-04 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32256 DEVICE: VITREA2 VERSION 3.5 VITAL IMAGES, INC. 510(k) NO: K040305(TRADITIONAL) ATTN: TIMOTHY J KAPPERS PHONE NO : 763-852-6914 3300 FERNBROOK LN. NORTH SE DECISION MADE: 24-FEB-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 THIRD PARTY REVIEW DEVICE: 40 L HIGH FLOW INSUFFLATOR F108 W.O.M. WORLD OF MEDICINE AG 510(k) NO: K030837(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 703-299-0523 368 NORTH ASAPH STREET SE DECISION MADE: 05-FEB-04 ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENS WESTCON CONTACT LENS CO., INC. 510(k) NO: K031774(TRADITIONAL) ATTN: CAROL NOBEL PHONE NO : 970-245-3845 611 EISENHAUER ST. SE DECISION MADE: 20-FEB-04 GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES WHEATON FRANCISCAN SERVICES INC., 510(k) NO: K033615(TRADITIONAL) ATTN: JACK SPEER PHONE NO : 801-582-6470 1800 EAST 900 SOUTH SE DECISION MADE: 13-FEB-04 SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS C WIENER LABORATORIES S.A.I.C. 510(k) NO: K023889(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191 2944 RIOBAMBA SE DECISION MADE: 11-FEB-04 ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING WILSON-COOK MEDICAL, INC. 510(k) NO: K040129(SPECIAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 27-FEB-04 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILSON-COOK USW CAP AND WIRE LOCK WILSON-COOK MEDICAL, INC. 510(k) NO: K040137(TRADITIONAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 20-FEB-04 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OASIS BILIARY STENT INTRODUCTION SYSTEM WILSON-COOK MEDICAL, INC. 510(k) NO: K040151(SPECIAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 20-FEB-04 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND WITT BIOMEDICAL CORP 510(k) NO: K033030(TRADITIONAL) ATTN: ELFRIEDE PAGAN PHONE NO : 321-253-5693 305 NORTH DR. SE DECISION MADE: 24-FEB-04 MELBOURNE, FL 32934 510(k) STATEMENT DEVICE: ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K033802(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 27-FEB-04 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS ZIMMER, INC. 510(k) NO: K033011(TRADITIONAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 574-372-4944 P.O. BOX 708 SE DECISION MADE: 12-FEB-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS ZIMMER, INC. 510(k) NO: K033223(TRADITIONAL) ATTN: KAREN CAIN PHONE NO : 574-372-4219 P.O. BOX 708 SE DECISION MADE: 18-FEB-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT ZIMMER, INC. 510(k) NO: K033652(TRADITIONAL) ATTN: STEPHEN MCKELVEY PHONE NO : 574-372-4944 P.O. BOX 708 SE DECISION MADE: 04-FEB-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 251 TOTAL WITH SUMMARIES 210 TOTAL WITH STATEMENTS 41
Updated 3/5/2004
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