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510(k)s Final Decisions Rendered for June 2004 |
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 SYSTEMINTL., 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
Updated July 6, 2004
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