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Medical Devices
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June 2004 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUN-2004 THROUGH 30-JUN-2004
DEVICE: MEDIA CULTURE SYSTEM
GENX INTL., INC. 510(k) NO: K040530(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW RD. SE DECISION MADE: 25-JUN-04
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
ABBOTT LABORATORIES 510(k) NO: K041550(TRADITIONAL)
ATTN: PATRICIA MELERSKI PHONE NO : 847-938-3718
D-389, BLDG. J45-2 SE DECISION MADE: 30-JUN-04
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6157 THIRD PARTY REVIEW
DEVICE: CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
ACCURAY, INC. 510(k) NO: K041315(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-416-4628
1310 CHESAPEAKE TERRACE SE DECISION MADE: 10-JUN-04
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FSH MENOPAUSE PREDICTOR TEST
ACON LABORATORIES, INC. 510(k) NO: K041165(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 17-JUN-04
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
ADAC LABORATORIES 510(k) NO: K041577(TRADITIONAL)
ATTN: RANDY VADER PHONE NO : 608-288-6945
6400 ENTERPRISE LANE,STE.201 SE DECISION MADE: 25-JUN-04
MADISON, WI 53719 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
ADVANCED UROLOGICAL DEVELOPMENTS 510(k) NO: K040817(TRADITIONAL)
ATTN: GERMAN BORODULIN PHONE NO : 650-412-0002
485 DARTMOUTH AVENUE SE DECISION MADE: 22-JUN-04
SAN CARLOS, CA 94070 510(k) STATEMENT
DEVICE: COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
ADVANCED VASCULAR DYNAMICS 510(k) NO: K040615(SPECIAL)
ATTN: HERBERT J SEMLER PHONE NO : 503-223-2333
2326 NW EVERETT ST. SE DECISION MADE: 01-JUN-04
PORTLAND, OR 97210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
AESCULAP 510(k) NO: K040864(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 17-JUN-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESKULISA ANA HEP-2
AESKU, INC 510(k) NO: K040953(TRADITIONAL)
ATTN: STANLEY AMMONS PHONE NO : 703-860-5057
8880 NORTHWEST 18TH TERRACE SE DECISION MADE: 23-JUN-04
MIAMI, FL 33172 510(k) STATEMENT
DEVICE: AIR SAFETY HEPA, MODEL 3500
AIR SAFETY LTD 510(k) NO: K040712(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 03-JUN-04
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RED, WHITE & BLUE
ALLESEE ORTHODONTIC APPLIANCES 510(k) NO: K040874(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 18-JUN-04
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
AMBU, INC. 510(k) NO: K041026(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY ROAD SE DECISION MADE: 28-JUN-04
LINTHICUM, MD 21090-1356 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE
ANGIODYNAMICS, INC. 510(k) NO: K040728(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 18-JUN-04
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DE
ANTHOGYR 510(k) NO: K040674(TRADITIONAL)
ATTN: ERIC GENEVE PHONE NO : 33 4 50580237
164 RUE DE TROIS LACS SE DECISION MADE: 30-JUN-04
SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
APL INTERNATIONAL INCORPORATED LIM510(k) NO: K033533(TRADITIONAL)
ATTN: LEE SON HONG PHONE NO : 008 461 543298
LONG THANH DISTRICT SE DECISION MADE: 24-JUN-04
DONG NAU PROVINCE 510(k) STATEMENT
DONG NAU, VIETNAM
DEVICE: LED TURBO-PEN
APOZA ENTERPRISE CO. LTD. 510(k) NO: K041303(TRADITIONAL)
ATTN: SHIN MIN TEH PHONE NO : 886 2 29010620
6 F,NO.657, CHUANG CHENG ROAD SE DECISION MADE: 18-JUN-04
HSIN-CHUANG CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) 242
DEVICE: BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
ARIZANT HEALTHCARE INC. 510(k) NO: K041686(SPECIAL)
ATTN: DAVID WESTLIN PHONE NO : 952-947-1277
10393 WEST 70TH ST. SE DECISION MADE: 30-JUN-04
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNERVUE DIAGNOSTIC SCOPE SYSTEM
ARTHROTEK, INC. 510(k) NO: K040604(TRADITIONAL)
ATTN: KACY ARNOLD PHONE NO : 574-267-6639
56 EAST BELLE DR. SE DECISION MADE: 04-JUN-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: FEMORAL HOOK
ARTHROTEK, INC. 510(k) NO: K041261(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-372-1568
P.O. BOX 587 SE DECISION MADE: 07-JUN-04
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SEC
ATRION MEDICAL PRODUCTS, INC. 510(k) NO: K041158(TRADITIONAL)
ATTN: DAN CLARK PHONE NO : 256-586-1580
1426 CURT FRANCIS RD. SE DECISION MADE: 16-JUN-04
ARAB, AL 35016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY
BARCO NV BARCOVIEW 510(k) NO: K033859(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 02-JUN-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: COLLEAGUE VOLUMETRIC INFUSION PUMPS
BAXTER HEALTHCARE CORP. 510(k) NO: K041191(TRADITIONAL)
ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825
RT. 120 & WILSON RD. SE DECISION MADE: 25-JUN-04
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
BAYER HEALTHCARE, LLC 510(k) NO: K040425(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 14-JUN-04
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K040767(TRADITIONAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 07-JUN-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK HEMATOLOGY CONTROL (A)
BIO-RAD 510(k) NO: K041457(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 28-JUN-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-RAD D-10 DUAL PROGRAM
BIO-RAD LABORATORIES, INC. 510(k) NO: K041444(TRADITIONAL)
ATTN: JACKIE BUCKLEY PHONE NO : 510-741-5309
4000 ALFRED NOBEL DR. SE DECISION MADE: 09-JUN-04
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
BIOCHECK, INC. 510(k) NO: K040030(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE. SE DECISION MADE: 16-JUN-04
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODERM SCIENCES WOUND DRESSING
BIODERM SCIENCES, INC. 510(k) NO: K040683(TRADITIONAL)
ATTN: EDWARD R GUBISH PHONE NO : 301-216-3912
101 ORCHARD RIDGE DR. SE DECISION MADE: 04-JUN-04
SUITE 1N 510(k) SUMMARY AVAILABLE FROM FDA
GAITHERSBURG, MD 20878
DEVICE: BMLS03-3
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K033174(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 30-JUN-04
VISTA, CA 92085-1360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 ESBL TEST
BIOMERIEUX, INC. 510(k) NO: K040845(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 08-JUN-04
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
BIOMERIEUX, INC. 510(k) NO: K040882(TRADITIONAL)
ATTN: SANDRA PERREAND PHONE NO : 314-731-8594
595 ANGLUM RD. SE DECISION MADE: 10-JUN-04
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSA-DIAL HUMERAL HEAD
BIOMET MANUFACTURING, INC. 510(k) NO: K040610(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-372-1568
P.O. BOX 587 SE DECISION MADE: 04-JUN-04
WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSCREW SCREW ANCHOR
BIOMET ORTHOPEDICS, INC. 510(k) NO: K033355(TRADITIONAL)
ATTN: MARY L VERSTYNEN PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 30-JUN-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMP
BIOMET, INC. 510(k) NO: K033489(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 02-JUN-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MODULAR RADIAL HEAD REPLACEMENT DEVICE
BIOMET, INC. 510(k) NO: K040611(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
56 EAST BELL DR. SE DECISION MADE: 04-JUN-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
BIOPSY SCIENCES, LLC 510(k) NO: K041331(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON RD. SE DECISION MADE: 15-JUN-04
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE PROFILER S.O.B. PANEL
BIOSITE INCORPORATED 510(k) NO: K040437(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 25-JUN-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONAMATES SERIES
BIOTECH ONE, INC. 510(k) NO: K040650(TRADITIONAL)
ATTN: KAREN UYESUGI PHONE NO : 949-661-1271
92 COSTA BRAVA SE DECISION MADE: 03-JUN-04
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSG CATHETER SET
BIOTEQUE AMERICA, INC. 510(k) NO: K041094(TRADITIONAL)
ATTN: DENIS DORSEY PHONE NO : 215-750-8071
340 EAST MAPLE AVE., #204-C SE DECISION MADE: 17-JUN-04
LANGHORNE, PA 19047 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: PSI-TEC PERISTALTIC INFILTRATION PUMP
BYRON MEDICAL 510(k) NO: K040149(TRADITIONAL)
ATTN: REGINA S HARRIS PHONE NO : 520-573-0857
602 W. RILLITO ST. SE DECISION MADE: 03-JUN-04
TUCSON, AZ 85705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
CANON INC. 510(k) NO: K041546(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 23-JUN-04
LAKE SUCCESS, NY 11042 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
CARADYNE, LTD. 510(k) NO: K040862(TRADITIONAL)
ATTN: JOHN O'DEA PHONE NO : 011 353 91709011
PARKMORE BUSINESS PARK, SE DECISION MADE: 30-JUN-04
PARKMORE WEST 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
CARDINAL HEALTH 510(k) NO: K041418(TRADITIONAL)
ATTN: LAVENIA FORD PHONE NO : 847-785-3323
1500 WAUKEGAN RD. SE DECISION MADE: 10-JUN-04
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUANTIX OR VESSEL STABILIZER DEVICE
CARDIOSONIX, LTD. 510(k) NO: K041180(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 07-JUN-04
20 HATA'AS ST. 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: MODIFICATION TO CAREMATIX WELLNESS SYSTEM
CAREMATIX INC. 510(k) NO: K040966(TRADITIONAL)
ATTN: SUKHWANT KHANUJA PHONE NO : 312-371-3050
2 N. LASALLE ST. SE DECISION MADE: 02-JUN-04
SUITE 1805 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60602
DEVICE: CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS,
CAS MEDICAL SYSTEMS, INC. 510(k) NO: K033048(SPECIAL)
ATTN: RON JEFFREY PHONE NO : 203-488-6056
44 EAST INDUSTRIAL RD. SE DECISION MADE: 01-JUN-04
BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX SURGEON'S GLOVES
CEPHAS MEDICAL PRIVATE LTD. 510(k) NO: K031368(TRADITIONAL)
ATTN: THANGIAH IMMANUEL PHONE NO : 91 44 22621515
B13 MADRAS EXPORT PROCESSING SE DECISION MADE: 22-JUN-04
ZONE, TAMBARAM 510(k) SUMMARY AVAILABLE FROM FDA
CHENNAI TAMILNADU, INDIA 600 045
DEVICE: CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
CHOLESTECH CORP. 510(k) NO: K040579(TRADITIONAL)
ATTN: THOMAS E WORTHY PHONE NO : 510-732-7200
3347 INVESTMENT BLVD. SE DECISION MADE: 18-JUN-04
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUCLEOTOME PROBE SET, MODEL 21200
CLARUS MEDICAL, LLC. 510(k) NO: K040919(TRADITIONAL)
ATTN: TOM BARTHEL PHONE NO : 763-525-8403
1000 BOONE AVE. NORTH SE DECISION MADE: 01-JUN-04
MINNEAPOLIS, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDS HEMATOLOGY CALIBRATOR (CDS CAL)
CLINICAL DIAGNOSTIC SOLUTIONS, INC510(k) NO: K041130(ABBREVIATED)
ATTN: ANDREW SWANSON PHONE NO : 954-791-1773
1660 N.W. 65TH AVE., SUITE 2 SE DECISION MADE: 10-JUN-04
PLANTATION, FL 33313 510(k) STATEMENT
DEVICE: MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE
CODMAN & SHURTLEFF, INC. 510(k) NO: K041296(SPECIAL)
ATTN: KATHRYN WUNDER PHONE NO : 508-880-8351
325 PARAMOUNT DR. SE DECISION MADE: 10-JUN-04
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN DURAFORM DURAL GRAFT IMPLANT
CODMAN & SHURTLEFF, INC. 510(k) NO: K041518(SPECIAL)
ATTN: ELIZABETH DOLAN PHONE NO : 508-828-3262
325 PARAMOUNT DR. SE DECISION MADE: 22-JUN-04
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAY-PUT IMPREGNATED
COLTENE/WHALEDENT GMBH & CO. KG 510(k) NO: K041023(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748
CARE OF HENRY J. VOGELSTEIN SE DECISION MADE: 15-JUN-04
1349 LEXINGTON AVE. 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10128
DEVICE: CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, M
CONCENTRIC MEDICAL, INC. 510(k) NO: K040700(SPECIAL)
ATTN: KEVIN F MACDONALD PHONE NO : 650-938-2100
1380 SHOREBIRD WAY SE DECISION MADE: 21-JUN-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
CONTROL SOLUTIONS, INC. 510(k) NO: K041146(TRADITIONAL)
ATTN: BRETT WALACH PHONE NO : 630-357-9008
508 WEST 5TH. AVE. SE DECISION MADE: 08-JUN-04
NAPERVILLE, IL 60563 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018" DE
CORDIS EUROPA N.V. 510(k) NO: K040413(TRADITIONAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDER HORN DR. SE DECISION MADE: 21-JUN-04
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMEDENT CORE PASTE
COSMEDENT, INC. 510(k) NO: K040994(TRADITIONAL)
ATTN: JAMES L SANDRIK PHONE NO : 312-644-9586
401 NORTH MICHIGAN AVE. SE DECISION MADE: 03-JUN-04
SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60611
DEVICE: MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
COSMEDENT, INC. 510(k) NO: K041229(TRADITIONAL)
ATTN: JAMES L SANDRIK PHONE NO : 312-644-9586
401 NORTH MICHIGAN AVE. SE DECISION MADE: 17-JUN-04
SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60611
DEVICE: COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
COZART BIOSCIENCE LTD. 510(k) NO: K033743(TRADITIONAL)
ATTN: ROBERTO LIDDI PHONE NO : 44 012 35861483
45 MILTON PARK SE DECISION MADE: 03-JUN-04
ABINGDON,OXFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECAT HRRT
CTI PET SYSTEMS, INC. 510(k) NO: K040933(TRADITIONAL)
ATTN: M. ALAINE MEDIO PHONE NO : 865-218-2703
810 INNOVATION DR. SE DECISION MADE: 07-JUN-04
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
CURELIGHT LTD 510(k) NO: K041569(SPECIAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 30-JUN-04
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDE
DANVILLE MATERIALS, INC. 510(k) NO: K040952(TRADITIONAL)
ATTN: CRAIG BURNS PHONE NO : 925-838-7940
2021 OMEGA DR. SE DECISION MADE: 29-JUN-04
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
DATASCOPE CORP. 510(k) NO: K041281(SPECIAL)
ATTN: JOANN TAYLOR PHONE NO : 973-244-6123
15 LAW DR. SE DECISION MADE: 07-JUN-04
FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MO
DEFIBTECH, LLC 510(k) NO: K033896(TRADITIONAL)
ATTN: JOHN L ROGERS PHONE NO : 203-453-6654
753 BOSTON POST RD., SUITE 102 SE DECISION MADE: 16-JUN-04
GUILFORD, CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTM SYSTEM
DENTSPLY INTERNATIONAL 510(k) NO: K041335(SPECIAL)
ATTN: P JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 16-JUN-04
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENO NM LIGHT CURED DENTAL ADHESIVE
DENTSPLY INTERNATIONAL 510(k) NO: K041343(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA ST. SE DECISION MADE: 16-JUN-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: SMARTLITE PS PEN-STYLE LED CURING LIGHT
DENTSPLY INTERNATIONAL 510(k) NO: K041372(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA ST. SE DECISION MADE: 24-JUN-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: CALIBRA CEMENT
DENTSPLY INTL. 510(k) NO: K040906(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 16-JUN-04
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MOD
DENTSPLY INTL. 510(k) NO: K041141(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 16-JUN-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: SUMMIT OCT SPINAL SYSTEM
DEPUY SPINE, INC. 510(k) NO: K041203(SPECIAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMOUNT DR. SE DECISION MADE: 02-JUN-04
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWIFT ANTERIOR CERVICAL PLATE SYSTEM
DEPUY SPINE,INC 510(k) NO: K040655(SPECIAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867
325 PARAMONT DRIVE SE DECISION MADE: 02-JUN-04
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSOFT
DIREX SYSTEMS CORP. 510(k) NO: K040474(TRADITIONAL)
ATTN: LARISA GERSTEIN PHONE NO : 508-651-0900
11 MERCER RD. SE DECISION MADE: 23-JUN-04
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K040612(TRADITIONAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
3 HASADNAOT ST. SE DECISION MADE: 17-JUN-04
HERZLIYA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
DISCUS DENTAL, INC. 510(k) NO: K033785(TRADITIONAL)
ATTN: VIVIAN LAI PHONE NO : 310-845-8347
8550 HIGUERA ST. SE DECISION MADE: 18-JUN-04
CULVER CITY, CA 90232-2522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I
DOME IMAGING SYSTEMS, INC. 510(k) NO: K040443(TRADITIONAL)
ATTN: SUSAN HAMANN PHONE NO : 781-895-1155
400 FIFTH AVENUE SE DECISION MADE: 16-JUN-04
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
DRAEGER MEDICAL, INC. 510(k) NO: K040847(SPECIAL)
ATTN: GALE E WINARSKY PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 17-JUN-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
DR`A'GER MEDICAL AG & CO. KGAA 510(k) NO: K040642(SPECIAL)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 02-JUN-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALHEAT
DYNATHERM MEDICAL, INC. 510(k) NO: K040911(TRADITIONAL)
ATTN: JOHN R KANE PHONE NO : 650-777-3461
819 MITTEN RD., SUITE 42 SE DECISION MADE: 22-JUN-04
BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SOLARIS D890 THERAPY PROBE
DYNATRONICS CORP. 510(k) NO: K040729(TRADITIONAL)
ATTN: RON HATCH PHONE NO : 801-568-7000
7030 PARK CENTRE DR. SE DECISION MADE: 02-JUN-04
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIC36 AMPLIFIER
EB NEURO, S.P.A. 510(k) NO: K041198(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 01-JUN-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI DISTAL RADIUS PLATING SYSTEM
EBI, L.P. 510(k) NO: K040908(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 25-JUN-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CA
EDWARDS LIFESCIENCES LLC. 510(k) NO: K033464(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
ONE EDWARDS WAY SE DECISION MADE: 22-JUN-04
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOCHROME LCD MONITOR, MODEL RADIFORCE G22
EIZO NANAO CORPORATION 510(k) NO: K041597(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 24-JUN-04
MATTO-SHI 510(k) SUMMARY AVAILABLE FROM FDA
ISHIKAWA-KEN, JAPAN 924-8566
DEVICE: H-FLOW VALVE
ELCAM MEDICAL A.C.A.L. 510(k) NO: K034043(TRADITIONAL)
ATTN: TALI HAZAN PHONE NO : 972 4 6988120
KIBBUTZ BAR-AM SE DECISION MADE: 30-JUN-04
D.N. MEROM HAGALIL, ISRAEL 13860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH
ELITE INTERNATIONAL, INC. 510(k) NO: K040071(TRADITIONAL)
ATTN: BOBBY LING PHONE NO : 800-788-9486
18709 GREENBAY DR. SE DECISION MADE: 03-JUN-04
ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT
DEVICE: MEDICAL AIR COMPRESSOR
EVENT MEDICAL LTD 510(k) NO: K040220(TRADITIONAL)
ATTN: ROBBIE WALSH PHONE NO : 353 91 764472
6A LIOSBAN BUSINESS PARK SE DECISION MADE: 09-JUN-04
TUAM ROAD 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
EXACTECH, INC. 510(k) NO: K040613(SPECIAL)
ATTN: GARY MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 04-JUN-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
EXACTECH, INC. 510(k) NO: K040755(SPECIAL)
ATTN: REBECCA ROBERTS PHONE NO : 352-264-8890
2320 N.W. 66TH CT. SE DECISION MADE: 17-JUN-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
FELTON INTERNATIONAL, INC. 510(k) NO: K041280(SPECIAL)
ATTN: JIM STANLEY PHONE NO : 816-347-9224
200 NE MULBERRY SE DECISION MADE: 24-JUN-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
LEE'S SUMMIT, MO 64086
DEVICE: SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
FERTILITY SOLUTIONS, INC. 510(k) NO: K041240(TRADITIONAL)
ATTN: SUSAN A ROTHMANN, PH.D., HCLPHONE NO : 216-491-0030
13000 SHAKER BLVD. SE DECISION MADE: 02-JUN-04
CLEVELAND, OH 44120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HILUX LEDMAX 3
FIRST MEDICAL INFECTION CONTROL AS510(k) NO: K040956(TRADITIONAL)
ATTN: DAVID SMALL PHONE NO : 605-787-7717
3704-C BOREN DR. SE DECISION MADE: 14-JUN-04
GREENSBORO, NC 27407 510(k) STATEMENT
DEVICE: CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K040941(TRADITIONAL)
ATTN: JAMES THOMPSON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 10-JUN-04
EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEST NILE VIRUS IGM CAPTURE ELISA
FOCUS TECHNOLOGIES, INC. 510(k) NO: K040854(TRADITIONAL)
ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 30-JUN-04
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-EUROLIG INTERFERENCE SCREW
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K031939(TRADITIONAL)
ATTN: CHRISTINE QUENDEZ PHONE NO : 33 298 556895
ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 24-JUN-04
QUIMPER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
FUJINON, INC. 510(k) NO: K040048(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 07-JUN-04
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
FUKUDA DENSHI USA, INC. 510(k) NO: K033711(SPECIAL)
ATTN: LARRY D WALKER PHONE NO : 425-881-7737
17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 03-JUN-04
REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-BOND
GC AMERICA INC. 510(k) NO: K041471(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH STREET SE DECISION MADE: 29-JUN-04
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GC FUSION
GC AMERICA, INC. 510(k) NO: K041398(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 W. 127TH ST. SE DECISION MADE: 25-JUN-04
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GE DISCOVERY ST
GE HEALTHCARE 510(k) NO: K041543(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD SE DECISION MADE: 22-JUN-04
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE DISCOVERY ST SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K041220(TRADITIONAL)
ATTN: DAVID DUERSTELER PHONE NO : 262-312-7029
P.O. 414 SE DECISION MADE: 15-JUN-04
MILWAUKEE, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K040458(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 813-887-2133
8200 WEST TOWER AVE. SE DECISION MADE: 03-JUN-04
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO UNITY NETWORK ID
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K040559(SPECIAL)
ATTN: DIANA M THORSON PHONE NO : 714-247-4135
8200 WEST TOWER AVE. SE DECISION MADE: 04-JUN-04
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K041476(SPECIAL)
ATTN: LARRY A KROGER PH.D. PHONE NO : 262-544-3894
PO BOX 414 SE DECISION MADE: 17-JUN-04
MILWAUKEE, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUME VIEWER PLUS
GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K041521(TRADITIONAL)
ATTN: LARRY KRUEGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 22-JUN-04
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRECISION RXI ANALOG X-RAY SYSTEM
GENERAL MEDICAL MERATE S.P.A. 510(k) NO: K041605(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412
25 VIA PARTIGIANI SE DECISION MADE: 30-JUN-04
SERIATE (BG), ITALY 24068 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
GENZYME CORP. 510(k) NO: K040241(TRADITIONAL)
ATTN: FRED D LASKY PHONE NO : 617-591-5512
ONE KENDALL SQUARE SE DECISION MADE: 25-JUN-04
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
GENZYME CORP. 510(k) NO: K040868(TRADITIONAL)
ATTN: MICHAEL G HALPIN PHONE NO : 617-591-5836
500 KENDALL STREET SE DECISION MADE: 04-JUN-04
CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSURE ANTERIOR CERVICAL PLATE SYSTEM
GLOBUS MEDICAL, INC. 510(k) NO: K040721(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LANE SE DECISION MADE: 17-JUN-04
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOLDEN SPYDER, MODEL GS-300
GOLDEN TECHNOLOGIES, INC. 510(k) NO: K041341(SPECIAL)
ATTN: GENE R KULON PHONE NO : 800-624-6374
401 BRIDGE ST. SE DECISION MADE: 03-JUN-04
OLD FORGE, PA 18518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K040681(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 W. CENTRAL AVE., #D SE DECISION MADE: 03-JUN-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT
GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K041188(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 W. CENTRAL AVE., #D SE DECISION MADE: 01-JUN-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAICHEM CALCIUM (OCPC) LIQUID REAGENT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K041009(TRADITIONAL)
ATTN: JAMES J MILLER PHONE NO : 443-367-5526
9033 RED BRANCH RD. SE DECISION MADE: 25-JUN-04
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: RAICHEM BUN RATE REAGENT (LIQUID)
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K041051(TRADITIONAL)
ATTN: JAMES J MILLER PHONE NO : 443-367-5526
9033 RED BRANCH RD. SE DECISION MADE: 30-JUN-04
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: RAICHEM GLUCOSE UV (LIQUID)
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K041052(TRADITIONAL)
ATTN: JAMES J MILLER PHONE NO : 443-367-5526
9033 RED BRANCH RD. SE DECISION MADE: 30-JUN-04
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
HEMOCUE, INC. 510(k) NO: K041234(SPECIAL)
ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DR. SE DECISION MADE: 10-JUN-04
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: IMAGERAYI
HENRY SCHEIN, INC. 510(k) NO: K041580(TRADITIONAL)
ATTN: W. EDWARD JOHANSEN PHONE NO : 310-204-5530
11661 SAN VICENTE BOULEVARD SE DECISION MADE: 29-JUN-04
LOS ANGELES, CA 90049 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDI
HOFFRICHTER GMBH 510(k) NO: K041035(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER RD. SE DECISION MADE: 09-JUN-04
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
HOWMEDICA OSTEONICS CORP 510(k) NO: K040749(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
325 CORPORATE DR. SE DECISION MADE: 17-JUN-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000
HUDSON DIAGNOSTIC IMAGING LLC 510(k) NO: K040926(TRADITIONAL)
ATTN: MARTIN E WENDELKEN PHONE NO : 201-709-8500
610 BLVD. SE DECISION MADE: 10-JUN-04
ELMWOOD PARK, NJ 07407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STABIL-O-GRAPH
I.E.M. GMBH 510(k) NO: K041313(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 239-948-2001
11820 RED HIBISCUS DRIVE SE DECISION MADE: 18-JUN-04
BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K040834(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 W. EAU GALLIE BLVD. SE DECISION MADE: 03-JUN-04
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: IMALUX OCT PROBE GUIDE
IMALUX CORPORATION 510(k) NO: K041077(TRADITIONAL)
ATTN: STEPHANIE A.S. HARRINGTON PHONE NO : 216-502-0755
1771 EAST 30TH STREET SE DECISION MADE: 25-JUN-04
CLEVELAND, OH 44114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKELISA ANTHRAX-PA KIT
IMMUNETICS, INC. 510(k) NO: K040407(TRADITIONAL)
ATTN: ANDREW LEVIN PHONE NO : 617-896-9100
27 DRYDOCK AVENUE SE DECISION MADE: 03-JUN-04
BOSTON, MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K041402(SPECIAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-776-6913
4555 RIVERSIDE DR. SE DECISION MADE: 16-JUN-04
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTODETECT SYRINGE
INDIGO ORB, INC. 510(k) NO: K041590(TRADITIONAL)
ATTN: ROBERT CHIN PHONE NO : 650-593-5225
2355 CALLE DE LUNA SE DECISION MADE: 23-JUN-04
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STARPACS ORTHOPEDICS SYSTEM
INFINITT CO., LTD. 510(k) NO: K041500(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 904-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 21-JUN-04
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUANTA LITE GP210 ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K040885(TRADITIONAL)
ATTN: GARY L NORMAN PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 25-JUN-04
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: ULTRACLIP II MR
INRAD 510(k) NO: K041201(SPECIAL)
ATTN: MELISSA LALOMIA PHONE NO : 616-301-7800
4375 DONKER COURT S.E. SE DECISION MADE: 03-JUN-04
KENTWOOD, MI 49512 510(k) STATEMENT
DEVICE: INSPEKTOR PRO
INSPEKTOR DENTAL CARE BV 510(k) NO: K040063(TRADITIONAL)
ATTN: ELBERT WALLER PHONE NO : 312 067 64988
QUELLINJNSTRAAT 92 SE DECISION MADE: 24-JUN-04
AMSTERDAM, NETHERLANDS 1072 XX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTEAD INTIMATE LUBRICANT
INSTEAD, INC. 510(k) NO: K033776(TRADITIONAL)
ATTN: JOE PIKE PHONE NO : 858-642-7515
4370 LA JOLLA VILLAGE DR. SE DECISION MADE: 25-JUN-04
SUITE 960 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92122
DEVICE: STRAUMANN DENTAL IMPLANT SYSTEM
INSTITUT STRAUMANN AG 510(k) NO: K033984(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 781-890-0001
RESERVOIR PLACE SE DECISION MADE: 30-JUN-04
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: INTEGRA BONE FIXATION SYSTEM
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K040860(TRADITIONAL)
ATTN: DONNA R WALLACE PHONE NO : 609-936-2397
311 ENTERPRISE DR. SE DECISION MADE: 17-JUN-04
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPACS, VERSION 1.0
INTELLIGENT IMAGES SRL 510(k) NO: K041581(TRADITIONAL)
ATTN: MAURIZIO PAIGGIO PHONE NO : 39 010 3071634
VIALE CEMBRANO 4C/4 SE DECISION MADE: 22-JUN-04
GENOVA (GE), ITALY I-16148 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
INTERNACIONAL FARMACEUTICA, S.A. D510(k) NO: K041048(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD. SE DECISION MADE: 04-JUN-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
INTERNATIONAL HOSPITAL SUPPLY CO. 510(k) NO: K040853(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 31 20 4289591
AMSTEL 320-1 SE DECISION MADE: 21-JUN-04
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVACARE 3G TARSYS
INVACARE CORP. 510(k) NO: K033819(TRADITIONAL)
ATTN: CARROLL MARTIN PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 04-JUN-04
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44035-4190
DEVICE: ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
ISCIENCE SURGICAL CORPORATION 510(k) NO: K041108(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
2 DELPHINUS SE DECISION MADE: 22-JUN-04
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-1
LILY MEDICAL SUPPLIES CO., LTD. 510(k) NO: K032767(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 03-JUN-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SMARTPIN
LINVATEC BIOMATERIALS, INC. 510(k) NO: K041288(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 3 3165600
P.O. BOX 3 SE DECISION MADE: 10-JUN-04
HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: NC SP02 ADAPTER CABLE
MASIMO CORP. 510(k) NO: K041204(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 29-JUN-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOEY CLAMP OPENING TOOL
MATERNUS, INC. 510(k) NO: K041332(TRADITIONAL)
ATTN: RONALD B HICKS PHONE NO : 210-479-4001
15303 HUEBNER RD., BLDG. 10 SE DECISION MADE: 25-JUN-04
SAN ANTONIO, TX 78248 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXO2+, MODEL "A" AND "AE"
MAXTEC, INC. 510(k) NO: K040484(TRADITIONAL)
ATTN: GORDON R ROTH PHONE NO : 801-266-5300
6526 SOUTH COTTONWOOD ST. SE DECISION MADE: 09-JUN-04
SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
MCCUE PLC 510(k) NO: K040659(TRADITIONAL)
ATTN: STEVEN PEACH PHONE NO : 44 148 9795668
SOLENT INDUSTRIAL ESTATE SE DECISION MADE: 01-JUN-04
HEDGE END. 510(k) SUMMARY AVAILABLE FROM FDA
SOUTHAMPTON, HAMPSHIRE, UNITED KINTHIRD PARTY REVIEW
DEVICE: MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
MEDEGEN MEDICAL MANUFACTURING SERV510(k) NO: K041179(SPECIAL)
ATTN: TIM TRUITT PHONE NO : 909-390-9080
930 WANAMAKER SE DECISION MADE: 04-JUN-04
ONTARIO, CA 91761-8151 510(k) STATEMENT
DEVICE: HEXAPOD RT COUCHTOP
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K041448(TRADITIONAL)
ATTN: SANDOR CSABA ATS PHONE NO : 490 761 612092
FEYERABENDSTRASSE 13-15 SE DECISION MADE: 16-JUN-04
SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIPRO MODEL SDS-CB200
MEDICAL SOLUTIONS INTERNATIONAL 510(k) NO: K033118(TRADITIONAL)
ATTN: JACK DILLON PHONE NO : 913-428-9700
11522 W 90TH ST. SE DECISION MADE: 28-JUN-04
OVERLAND PARK, KS 66214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
MEDICEL AG 510(k) NO: K040837(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 17-JUN-04
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRA-CMS
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K040746(TRADITIONAL)
ATTN: J.I. HOLLANDER PHONE NO : 317 152 23244
SCHUTTERSVELD 9 SE DECISION MADE: 08-JUN-04
LEIDEN, NETHERLANDS 2316 XG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELASTIC SKIN LIQUID BANDAGE
MEDPAK, LLC 510(k) NO: K032948(TRADITIONAL)
ATTN: JOSEPH G SANT'ANGELO PHONE NO : 610-530-0530
568 PARKSIDE COURT SE DECISION MADE: 25-JUN-04
ALLENTOWN, PA 18104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC PS MEDICAL STRATA VALVE
MEDTRONIC NEUROSURGERY 510(k) NO: K040943(TRADITIONAL)
ATTN: JEFF HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR., SE DECISION MADE: 15-JUN-04
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K041030(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 30-JUN-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K041452(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 24-JUN-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K041282(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 10-JUN-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPORT CATHETER
MEDTRONIC, INC. 510(k) NO: K040869(TRADITIONAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 01-JUN-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K040699(TRADITIONAL)
ATTN: RONDA MAGNESON PHONE NO : 801-576-9669
11506 SOUTH STATE ST. SE DECISION MADE: 04-JUN-04
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333
MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K023956(TRADITIONAL)
ATTN: JOHN CHEN PHONE NO : 661-269-1006
7F,86,SEC.1, KWANG FU ROAD SE DECISION MADE: 17-JUN-04
SAN CHUNG CITY, CHINA (TAIWAN) 241510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K040704(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 914-667-3999
521 HOMESTEAD AVE. SE DECISION MADE: 18-JUN-04
MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA BUPRENORPHINE ASSAY
MICROGENICS CORP. 510(k) NO: K040316(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 510-979-5210
46360 FREMONT BLVD. SE DECISION MADE: 23-JUN-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODEL
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K040723(ABBREVIATED)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 10-JUN-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
MIGUN MEDICAL INSTRUMENT CO. LTD. 510(k) NO: K041200(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810
5905 FAWN LANE SE DECISION MADE: 17-JUN-04
CLEVELAND, OH 44141 510(k) STATEMENT
DEVICE: MIS DENTAL IMPLANT SYSTEM
MIS - IMPLANT TECHNOLOGIES LTD. 510(k) NO: K040807(TRADITIONAL)
ATTN: MOTTI WEISMAN PHONE NO : 201-797-9144
278 BROADWAY SE DECISION MADE: 09-JUN-04
ELMWOOD PARK, NJ 07407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K030831(TRADITIONAL)
ATTN: DAVID LOU PHONE NO : 852 242 09068
35-41 TAI LIN PAI RD., UNIT F, SE DECISION MADE: 15-JUN-04
5TH FL., GOLD KING IND. BLDG. 510(k) STATEMENT
KWAI CHUNG, N.T., HONG KONG
DEVICE: MODERN MEDICAL BIPOLAR FORCEPS
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K032327(TRADITIONAL)
ATTN: DAVID LOU PHONE NO : 852 242 09068
35 TAI LIN PAI RD. SE DECISION MADE: 15-JUN-04
GOLD KING IND. BLDG. 510(k) STATEMENT
KWAI CHUNG, N.T., HONG KONG
DEVICE: SOFTSEAL HSG CATHETER
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K040238(TRADITIONAL)
ATTN: AL MUZZAMMEL PHONE NO : 804-353-7160
1705 DABNEY RD. SE DECISION MADE: 22-JUN-04
RICHMOND, VA 23230 510(k) STATEMENT
DEVICE: TELENABLE EMS SYSTEM
MOLEX, INC. 510(k) NO: K040663(TRADITIONAL)
ATTN: EUGENE H DIBBLE PHONE NO : 312-326-3200
P.O. BOX 53142 SE DECISION MADE: 30-JUN-04
CHICAGO, IL 60653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3 MICROKERATOME
MORIA S.A. 510(k) NO: K032836(TRADITIONAL)
ATTN: MELANIE RENAUD-SAMIRI PHONE NO : 33 1 46744636
15 RUE GEORGES BESSE SE DECISION MADE: 18-JUN-04
ANTONY, FRANCE 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCYON SPINAL SYSTEM
NAS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K033512(TRADITIONAL)
ATTN: MAKOTO NONAKA PHONE NO : 858-452-5589
9191 TOWNE CENTRE DRIVE SE DECISION MADE: 03-JUN-04
SUITE 395 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92122
DEVICE: HOUVA 3 PHOTOTHERAPY SYSTEM
NATIONAL BIOLOGICAL CORP. 510(k) NO: K041212(SPECIAL)
ATTN: LORETTA MOONEY PHONE NO : 330-425-3535
1532 ENTERPRISE PKWY. SE DECISION MADE: 09-JUN-04
TWINSBURG, OH 44087 510(k) STATEMENT
DEVICE: NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS
NATIONAL DISPLAY SYSTEMS 510(k) NO: K040310(TRADITIONAL)
ATTN: RON HANSEN PHONE NO : 408-776-0085
16245 VINEYARD BLVD. SE DECISION MADE: 17-JUN-04
MORGAN HILL, CA 95037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EN-BLOC BIOPSY SYSTEM
NEOTHERMIA CORP. 510(k) NO: K041347(SPECIAL)
ATTN: SHERRIE COVAL-GOLDSMITH PHONE NO : 508-655-7820
ONE APPLE HILL SUITE 316 SE DECISION MADE: 04-JUN-04
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SY
NEUSOFT DIGITAL MEDICAL SYSTEMS CO510(k) NO: K041542(TRADITIONAL)
ATTN: WANG ZHIQIANG PHONE NO : 86 24 83665003
NO.3-11, WENHUA ROAD SE DECISION MADE: 17-JUN-04
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE,
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K040813(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-940-7260
1311 CALLE BATIDO SE DECISION MADE: 08-JUN-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K040395(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 01-JUN-04
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AVANT 9600 PULSE OXIMETER
NONIN MEDICAL, INC. 510(k) NO: K040589(SPECIAL)
ATTN: JOHN R DALPEE PHONE NO : 763-577-3166
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 03-JUN-04
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
NONIN MEDICAL, INC. 510(k) NO: K041156(TRADITIONAL)
ATTN: JOHN R DALPEE PHONE NO : 763-577-3166
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 09-JUN-04
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R-TEST EVOLUTION 3
NOVACOR 510(k) NO: K040753(SPECIAL)
ATTN: DOMINIQUE GRENIER PHONE NO : 33 141 390578
4, PASSAGE SAINT-ANTOINE SE DECISION MADE: 10-JUN-04
RUEIL MALMAISON CEDEX, FRANCE 9250510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
NUMED, INC. 510(k) NO: K040830(SPECIAL)
ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 18-JUN-04
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUMED PTS X SIZING BALLOON CATHETER
NUMED, INC. 510(k) NO: K041306(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 10-JUN-04
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BBP BONE SUBSTITUTES
OCT, USA, INC. 510(k) NO: K030195(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 17-JUN-04
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: EYE SPHERE IMPLANTS
OCULO PLASTIK, INC. 510(k) NO: K040689(TRADITIONAL)
ATTN: JEAN-FRANCOIS DRETTE PHONE NO : 514 381 3292
200 SAUVE WEST SE DECISION MADE: 10-JUN-04
MONTREAL, QUEBEC, CANADA H3L 1Y9 510(k) STATEMENT
DEVICE: S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT
OPTICAL CONNECTION, INC. 510(k) NO: K040900(TRADITIONAL)
ATTN: GAROLD L EDWARDS PHONE NO : 408-221-3860
2091 UPPER SCENIC DRIVE SE DECISION MADE: 15-JUN-04
FELTON, CA 95018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSILASE PAD 3000
OPTICAL SENSORS, INC. 510(k) NO: K040654(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LENANGER LN. SE DECISION MADE: 04-JUN-04
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM ANCHOR WITH INSERTER
OPUS MEDICAL, INC. 510(k) NO: K041440(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 25-JUN-04
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K041370(SPECIAL)
ATTN: JIM CLOSSICK PHONE NO : 954-730-0711
5363 N.W. 35TH AVE. SE DECISION MADE: 24-JUN-04
FT. LAUDERDALE, FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RAN
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K041322(SPECIAL)
ATTN: SARAH PARSONS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 17-JUN-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSY SHOULDER PLATE IMPLANT
ORTHOPEDIC SCIENCES, INC 510(k) NO: K040850(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON RD. SE DECISION MADE: 24-JUN-04
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
ORTHOSOFT, INC. 510(k) NO: K041369(SPECIAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 22-JUN-04
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADENT PROPHY PASTE
PASCAL CO., INC. 510(k) NO: K040661(TRADITIONAL)
ATTN: VINCENT M TENTARELLI PHONE NO : 425-602-3633
2929 N.E. NORTHUP WAY SE DECISION MADE: 09-JUN-04
BELLEVUE, WA 98004 510(k) STATEMENT
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K041214(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 07-JUN-04
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EG-3630UR
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K041395(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 845-365-0700
30 RAMLAND RD. SE DECISION MADE: 09-JUN-04
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FG-36UX FIBER ULTRASOUND GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K041396(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 914-365-0700
30 RAMLAND RD. SE DECISION MADE: 09-JUN-04
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EG-3830UT
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K041397(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 845-365-0700
30 RAMLAND RD. SE DECISION MADE: 09-JUN-04
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO M2376A DEVICELINK SYSTEM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K041401(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 49 703 14631734
HEWLETT PACKARD STR. 2 SE DECISION MADE: 04-JUN-04
BOBLINGEN, GERMANY D71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE P
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K041235(SPECIAL)
ATTN: MARKUS STACHA PHONE NO : 49 703 14632840
HEWLETT-PACKARD STR.2 SE DECISION MADE: 04-JUN-04
BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8,
PM DEVICES, INC. 510(k) NO: K033985(TRADITIONAL)
ATTN: BRITTA DOMBOVARI PHONE NO : 604 270 4344
2135-13700 MAYFIELD PLACE SE DECISION MADE: 04-JUN-04
RICHMOND, BC, CANADA V6V 2E4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
PM DEVICES, INC. 510(k) NO: K040835(TRADITIONAL)
ATTN: BRITTA DOMBOVARI PHONE NO : 604 270 4344
2135-13700 MAYFIELD PLACE SE DECISION MADE: 15-JUN-04
RICHMOND, BC, CANADA V6V 2E4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT
POINTE SCIENTIFIC, INC. 510(k) NO: K040391(TRADITIONAL)
ATTN: RON JAMISON PHONE NO : 313-383-7220
1025 JOHN A. PAPALAS DR. SE DECISION MADE: 02-JUN-04
LINCOLN PARK, MI 48146 510(k) STATEMENT
DEVICE: POISE DATAENGINE
POISE TECHNOLOGY CORPORATION 510(k) NO: K040969(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 08-JUN-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
POLYMEDCO, INC. 510(k) NO: K040332(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 425-814-1514
510 FURNACE DOCK RD. SE DECISION MADE: 16-JUN-04
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
POREX SURGICAL, INC. 510(k) NO: K040364(TRADITIONAL)
ATTN: HOWARD MERCER PHONE NO : 678-479-1610
15 DART RD. SE DECISION MADE: 30-JUN-04
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K040720(TRADITIONAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
110 UNION SQUARE DR. SE DECISION MADE: 03-JUN-04
NEW HOPE, PA 18938 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCHECK CLOT C
PRECISION BIOLOGIC INC. 510(k) NO: K040987(TRADITIONAL)
ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 18-JUN-04
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE SLEEP DATA RECORDER (PSDR)
PRO-TECH SERVICES, INC. 510(k) NO: K033402(TRADITIONAL)
ATTN: NEIL SHELLER PHONE NO : 425-322-0304
4338 HARBOUR POINTE BLVD. S.W. SE DECISION MADE: 30-JUN-04
MUKILTEO, WA 98275 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
PT. SMART GLOVE INDONESIA 510(k) NO: K040791(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 006 206 17944946
KAWASAN INDUSTRI MEDAN STAR J1 SE DECISION MADE: 03-JUN-04
RAYA MEDAN-LUBUK PAKAM KM.19 510(k) STATEMENT
TG MORAWA-DELI SERDANG UTARA, INDONESIA 20362
DEVICE: MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
PULMONETIC SYSTEMS, INC. 510(k) NO: K040790(SPECIAL)
ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305
17400 MEDINA RD. SE DECISION MADE: 03-JUN-04
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447
DEVICE: QBTEST
QBTECH AB 510(k) NO: K040894(TRADITIONAL)
ATTN: MARIA BERGLUND PHONE NO : 46 31 7749060
MIMERGATAN 5 SE DECISION MADE: 22-JUN-04
GOTEBORG, SWEDEN 417 64 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
QUEST DIAGNOSTICS, INC. 510(k) NO: K040257(TRADITIONAL)
ATTN: PATRICK CARPENTER PHONE NO : 800-443-2750
4230 BURNHAM AVE. SE DECISION MADE: 14-JUN-04
LAS VEGAS, NV 89119-5410 510(k) STATEMENT
DEVICE: IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
R2 TECHNOLOGY, INC. 510(k) NO: K041380(TRADITIONAL)
ATTN: KATHY O'SHAUGHNESSY PHONE NO : 408-481-5696
1195 W. FREMONT AVE. SE DECISION MADE: 08-JUN-04
SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RANDOX AMIKACIN
RANDOX LABORATORIES, LTD. 510(k) NO: K033884(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 09-JUN-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX IMMUNOASSAY CONTROL
RANDOX LABORATORIES, LTD. 510(k) NO: K040379(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 28 94422413
55 DIAMOND RD. SE DECISION MADE: 16-JUN-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: IPACS ORTHO
REAL TIME IMAGE INC. 510(k) NO: K041366(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 08-JUN-04
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RELIANT LASER SYSTEM II
RELIANT TECHNOLOGIES, INC. 510(k) NO: K040617(TRADITIONAL)
ATTN: HEATHER TANNER PHONE NO : 650-473-0200
260 SHERIDAN AVE. SE DECISION MADE: 15-JUN-04
SUITE 309 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94306
DEVICE: VPAP III ST-A
RESMED LTD. 510(k) NO: K033276(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 07-JUN-04
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESCONTROL II
RESMED LTD. 510(k) NO: K040944(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2282
14040 DANIELSON ST. SE DECISION MADE: 03-JUN-04
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K041412(SPECIAL)
ATTN: MARY FUNK PHONE NO : 760-918-7300
2271 COSMOS CT. SE DECISION MADE: 18-JUN-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NICO WITH MARS, MODEL 7300
RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K041450(SPECIAL)
ATTN: KEVIN MADER PHONE NO : 203-697-6466
5 TECHNOLOGY DR. SE DECISION MADE: 18-JUN-04
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICINAL LEECHES
RICARIMPEX SAS 510(k) NO: K040187(TRADITIONAL)
ATTN: BRIGITTE LATRILLE PHONE NO : 335 565 78412
245 AVENUE DE SAINT MEDARD SE DECISION MADE: 21-JUN-04
33320 EYSINES 510(k) SUMMARY AVAILABLE FROM FDA
FRANCE, FRANCE
DEVICE: HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CA
ROCHESTER MEDICAL CORP. 510(k) NO: K033477(TRADITIONAL)
ATTN: ROB ANGLIN PHONE NO : 507-533-9600
ONE ROCHESTER MEDICAL DR. SE DECISION MADE: 10-JUN-04
STEWARTVILLE, MN 55976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
SCHICK TECHNOLOGIES, INC. 510(k) NO: K041385(SPECIAL)
ATTN: DANIEL MICHAELI PHONE NO : 718-482-2159
30-00 47TH AVE. SE DECISION MADE: 07-JUN-04
LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALADYN RIGID SPINE PLATE
SCIENT'X 510(k) NO: K040747(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 17-JUN-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITIVE SKIN ANTIBACTERIAL BANDAGES
SCIVOLUTION, INC. 510(k) NO: K032983(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-649-0856
962 ALLEGRO LANE SE DECISION MADE: 01-JUN-04
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINA
SHANGHAI FOREMOST PLASTIC INDUSTRI510(k) NO: K041041(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
13900 49TH STREET NORTH SE DECISION MADE: 08-JUN-04
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ONEDOSE PATIENT DOSIMETRY SYSTEM
SICEL TECHNOLOGIES INC 510(k) NO: K040687(TRADITIONAL)
ATTN: TAMMY B CARREA PHONE NO : 919-465-2236
3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 25-JUN-04
SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K041319(SPECIAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-694-5004
1230 SHOREBIRE WAY SE DECISION MADE: 07-JUN-04
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: AXIOM ARTIS U
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K040675(TRADITIONAL)
ATTN: DEBRA PEACOCK PHONE NO : 610-448-1773
51 VALLEY STREAM PARKWAY SE DECISION MADE: 10-JUN-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOCLAIR ORAL GEL
SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K040950(TRADITIONAL)
ATTN: MICHAEL KILLEEN PHONE NO : 972-939-2442
2340 TRINITY MILLS SE DECISION MADE: 21-JUN-04
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
CARROLLTON, TX 75006
DEVICE: JAX-TCP
SMITH & NEPHEW, INC. 510(k) NO: K033552(ABBREVIATED)
ATTN: KIM P KELLY PHONE NO : 901-399-6566
1450 E. BROOKS RD. SE DECISION MADE: 10-JUN-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR HA COATED RECONSTRUCTION RING
SMITH & NEPHEW, INC. 510(k) NO: K040680(TRADITIONAL)
ATTN: JOHN REABE PHONE NO : 901-399-6670
1450 BROOKS RD. SE DECISION MADE: 14-JUN-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURABRAID SUTURE
SMITH & NEPHEW, INC. 510(k) NO: K040789(ABBREVIATED)
ATTN: BILL MCCALLUM PHONE NO : 508-261-3600
150 MINUTEMAN RD. SE DECISION MADE: 04-JUN-04
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW ULTRABRAID SUTURE
SMITH & NEPHEW, INC. 510(k) NO: K041216(ABBREVIATED)
ATTN: DENISE LIMA PHONE NO : 508-337-4036
130 FORBES BLVD. SE DECISION MADE: 07-JUN-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
SONOSCAPE COMPANY LIMITED 510(k) NO: K041455(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302
7263 CRONIN CIRCLE SE DECISION MADE: 10-JUN-04
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGORA OPTIME (OR DIGORA ONTIME)
SOREDEX INSTRUMENTARIUM CORP. 510(k) NO: K041050(TRADITIONAL)
ATTN: KAI LANER PHONE NO : 358 103 94820
ELIMAENKATU 22 B SE DECISION MADE: 15-JUN-04
HELSINKI, FINLAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAFER SYSTEM
SPINE WAVE, INC. 510(k) NO: K033303(TRADITIONAL)
ATTN: RONALD K SMITH PHONE NO : 203-944-9494
TWO ENTERPRISE DR. SE DECISION MADE: 24-JUN-04
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484
DEVICE: SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
SPS MEDICAL SUPPLY CORP. 510(k) NO: K041017(TRADITIONAL)
ATTN: GARY J SOCOLA PHONE NO : 585-359-0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 25-JUN-04
RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RE-USEABLE MICROSTAAR INJECTOR, MSI-S
STAAR SURGICAL CO. 510(k) NO: K032412(TRADITIONAL)
ATTN: JASON K LYON PHONE NO : 626-303-7902
1911 WALKER AVE. SE DECISION MADE: 10-JUN-04
MONROVIA, CA 91016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
STELLARTECH RESEARCH CORP. 510(k) NO: K041383(SPECIAL)
ATTN: GARY A SEEGER PHONE NO : 408-331-3138
1346 BORDEAUX DR. SE DECISION MADE: 14-JUN-04
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER BIOZIP SUTURE ANCHOR SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K041305(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 408-754-2148
5900 OPTICAL CT. SE DECISION MADE: 14-JUN-04
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K041307(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 408-754-2148
5900 OPTICAL CT. SE DECISION MADE: 14-JUN-04
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER WEDGE SUTURE ANCHOR SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K041310(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 408-754-2148
5900 OPTICAL CT. SE DECISION MADE: 14-JUN-04
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA MPO ANCA, MODEL 17648/17696
SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K041040(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 497 614 7805310
MUNZINGER STRASSE 7 SE DECISION MADE: 16-JUN-04
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROQ - PET DP
SYNTERMED, INC. 510(k) NO: K041022(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256
3340 PEACHTREE RD NE SE DECISION MADE: 17-JUN-04
SUITE 1800 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30326
DEVICE: SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
SYNTHES (USA) 510(k) NO: K033868(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 21-JUN-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
SYNTHES (USA) 510(k) NO: K040701(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 15-JUN-04
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: LCP RADIAL HEAD PLATING SYSTEM
SYNTHES (USA) 510(k) NO: K040777(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 18-JUN-04
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: TAIDOC CHECK
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K041107(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080
4F, NO. 88, SEC.1, KWANG-FU RD SE DECISION MADE: 18-JUN-04
SAN-CHUNG 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM
TAKARA BELMONT USA, INC. 510(k) NO: K040748(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 02-JUN-04
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
TECNIMED S.R.L. 510(k) NO: K033790(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD. SE DECISION MADE: 03-JUN-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: THERMAGE THERMACOOL SYSTEM
THERMAGE, INC. 510(k) NO: K040135(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116
4058 POINT EDEN WAY SE DECISION MADE: 21-JUN-04
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-PUMP ASPIRATOR, MODEL 1615
THOMAS INDUSTRIES 510(k) NO: K041199(SPECIAL)
ATTN: DANIEL PFISTER PHONE NO : 920-451-4252
1419 ILLINOIS AVE. SE DECISION MADE: 01-JUN-04
SHEBOYGAN, WI 53082-0029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K040713(SPECIAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 01-JUN-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
THOMSON & NIELSEN ELECTRONICS, LTD510(k) NO: K041557(SPECIAL)
ATTN: MARY HERBERT PHONE NO : 613 596 4563
25-B NORTHSIDE RD. SE DECISION MADE: 25-JUN-04
OTTAWA, ONTARIO, CANADA K2H 8S1 510(k) STATEMENT
DEVICE: TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS
TIARA MEDICAL SYSTEMS, INC. 510(k) NO: K034053(TRADITIONAL)
ATTN: GEOFFREY SLEEPER PHONE NO : 216-521-1220
14414 DETROIT AVE, SUITE 205 SE DECISION MADE: 24-JUN-04
LAKEWOOD, OH 44107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS SHOULDER SYSTEM
TORNIER S.A. 510(k) NO: K041339(SPECIAL)
ATTN: MIREILLE LEMERY PHONE NO : 00 33 476613898
ZIRST-161, RUE LAVOISIER SE DECISION MADE: 17-JUN-04
MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSA-770A, APLIO VERSION 5.5
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K041499(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 10-JUN-04
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781 THIRD PARTY REVIEW
DEVICE: 21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)
TOTOKU ELECTRIC CO., LTD 510(k) NO: K040695(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 07-JUN-04
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)
TOTOKU ELECTRIC CO., LTD 510(k) NO: K040697(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 10-JUN-04
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRI
TYCO HEALTHCARE 510(k) NO: K032438(TRADITIONAL)
ATTN: DAVID OLSON PHONE NO : 508-261-8530
15 HAMPSHIRE ST. SE DECISION MADE: 30-JUN-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCD EXPRESS PORTABLE COMPRESSION SYSTEM
TYCO HEALTHCARE/KENDALL 510(k) NO: K040511(TRADITIONAL)
ATTN: BRIDGET GARDNER PHONE NO : 508-261-6384
15 HAMPSHIRE STREET SE DECISION MADE: 28-JUN-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARBLUE EASY EASY READ PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K041404(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 441 234 835564
PRIORY BUSINESS PARK SE DECISION MADE: 08-JUN-04
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY D
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K040494(TRADITIONAL)
ATTN: GRETCHEN Y COHEN PHONE NO : 440-639-4494
5976 HEISELY RD. SE DECISION MADE: 23-JUN-04
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE OVERTUBE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K040836(TRADITIONAL)
ATTN: GRETCHEN Y COHEN PHONE NO : 440-639-4494
5976 HEISELY RD. SE DECISION MADE: 10-JUN-04
MENTOR, OH 44060 510(k) STATEMENT
DEVICE: CONTACT DETACH
UNOMEDICAL A/S 510(k) NO: K041545(SPECIAL)
ATTN: JOHN M LINDSKOG PHONE NO : 45 46 427810
AAHOLMVEJ 1-3, OSTED SE DECISION MADE: 30-JUN-04
ROSKILDE, DENMARK DK-4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
USA INSTRUMENTS, INC. 510(k) NO: K041487(SPECIAL)
ATTN: JAMES WRENN PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 17-JUN-04
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEA
VALUMAX INTL., INC. 510(k) NO: K040333(TRADITIONAL)
ATTN: JANET JIA PHONE NO : 610-336-0101
848 HAUSMAN RD. SE DECISION MADE: 07-JUN-04
ALLENTOWN, PA 18104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLINDA/EXM
VANDERBILT UNIVERSITY 510(k) NO: K033960(TRADITIONAL)
ATTN: MICHAEL STABIN PHONE NO : 615-343-0068
1161 21ST AVENUE SOUTH SE DECISION MADE: 15-JUN-04
NASHVILLE, TN 37232-2675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
VASCULAR SOLUTIONS, INC. 510(k) NO: K040730(TRADITIONAL)
ATTN: DEBORAH L NEYMARK PHONE NO : 763-656-4349
6464 SYCAMORE COURT SE DECISION MADE: 18-JUN-04
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTLAB NASAL CPAP CANNULA
VENTLAB CORP. 510(k) NO: K040726(TRADITIONAL)
ATTN: ROBERT M KELLY PHONE NO : 336-753-5000
2934 HWY. 601 NORTH SE DECISION MADE: 03-JUN-04
MOCKSVILLE, NC 27028 510(k) STATEMENT
DEVICE: CELLSEARCH EPITHELIAL CELL CONTROL KIT
VERIDEX, LLC 510(k) NO: K040898(TRADITIONAL)
ATTN: DEBRA J RASMUSSEN PHONE NO : 908-704-3942
1001 US HWY 202 SE DECISION MADE: 28-JUN-04
RARITAN, NJ 08869-0606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRODERM, MODEL/VERSION 3.5
VISIOMED AG 510(k) NO: K040171(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH STREET SE DECISION MADE: 08-JUN-04
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMASK TM
VITAL SIGNS, INC. 510(k) NO: K041309(TRADITIONAL)
ATTN: THOMAS DIELMANN PHONE NO : 303-790-4835
11039 EAST LANSING CIRCLE SE DECISION MADE: 30-JUN-04
ENGLEWOOD, CO 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K040638(TRADITIONAL)
ATTN: SAM NANAVATI PHONE NO : 408-473-1100
2200 ZANKER RD., SUITE F SE DECISION MADE: 07-JUN-04
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBOMAP PRESSURE AND FLOW SYSTEM
VOLCANO THERAPEUTICS, INC. 510(k) NO: K041134(SPECIAL)
ATTN: LORRY W HUFFMAN PHONE NO : 916-638-9404
2870 KILGORE RD. SE DECISION MADE: 02-JUN-04
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502
VYGON S A 510(k) NO: K040657(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 909-699-6262
45900 PARSIPPANY COURT SE DECISION MADE: 10-JUN-04
TEMECULA, CA 92592 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRRIGATION TUBING SET 2.2M AND 3.8M
W&H DENTALWERK BURMOOS 510(k) NO: K041124(TRADITIONAL)
ATTN: RALF BENDA PHONE NO : 436 274 6236193
IGNAZ-GLASER-STR. 53 SE DECISION MADE: 07-JUN-04
BURMOOS, AUSTRIA A-5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMOTENURSE PATIENT MONITORING SYSTEM
WEBVMC, LLC 510(k) NO: K041308(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 28-JUN-04
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WILOSN-COOK BILIARY DILATION BALLOON
WILSON-COOK MEDICAL, INC. 510(k) NO: K040800(TRADITIONAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. & SE DECISION MADE: 25-JUN-04
5951 GRASSY CREEK BLVD. 510(k) SUMMARY AVAILABLE FROM FDA
WINSTON-SALEM, NC 27105
DEVICE: INCUBATOR CAPE
WRAPPED IN COMFORT 510(k) NO: K040794(TRADITIONAL)
ATTN: JANE GETSLA PHONE NO : 877-205-0901
15760 VIA SONATA SE DECISION MADE: 10-JUN-04
SAN LORENZO, CA 94580 510(k) STATEMENT
DEVICE: CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K041425(SPECIAL)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 25-JUN-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES
ZI BO HONG WANG PLASTIC & RUBBER P510(k) NO: K040967(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING ROAD SE DECISION MADE: 16-JUN-04
NORTH BILLERICA, MA 01862 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 279
TOTAL WITH SUMMARIES 236
TOTAL WITH STATEMENTS 43
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