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510(k)s Final Decisions Rendered for February 2004 |
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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-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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