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510(k)s Final Decisions Rendered for July 2004 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUL-2004 THROUGH 31-JUL-2004 DEVICE: LATIT FLOW AB ARDENT 510(k) NO: K040465(TRADITIONAL) ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591 54 RIVERVIEW AVE. SE DECISION MADE: 20-JUL-04 TONAWANDA, NY 14150-5260 510(k) STATEMENT DEVICE: ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING AB BIODISK 510(k) NO: K040560(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760 DALVAGEN 10 SE DECISION MADE: 27-JUL-04 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), ACCU-STAT DIAGNOSTICS, INC. 510(k) NO: K041221(TRADITIONAL) ATTN: JAMES G BARRONS PHONE NO : 949-916-7560 11 ORCHARD RD., SUITE 108 SE DECISION MADE: 13-JUL-04 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE CONNECT INTERNAL CONNECTION ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K041759(SPECIAL) ATTN: J. EDWARDS CARCHIDI PHONE NO : 508-588-3100 1034 PEARL ST. SE DECISION MADE: 22-JUL-04 BROCKTON, MA 02301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACELL UBM SURGICAL MESH ML AND MLPLUS ACELL, INC 510(k) NO: K041140(ABBREVIATED) ATTN: PATSY J TRISLER PHONE NO : 301-652-5344 5610 WISCONSIN AVE SE DECISION MADE: 07-JUL-04 #304 510(k) SUMMARY AVAILABLE FROM FDA CHEVY CHASE, MD 20815 DEVICE: EXTENTRAC ELITE ADVANCED BACK TECHNOLOGIES 510(k) NO: K031996(ABBREVIATED) ATTN: DAVID F CUCCIA PHONE NO : 516-364-1717 227 JACKSON AVE. SE DECISION MADE: 23-JUL-04 SYOSSET, NY 11791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKULISA ENA 6 S AESKU.DIAGNOSTICS 510(k) NO: K041753(TRADITIONAL) ATTN: STANLEY AMMONS PHONE NO : 703-860-5057 8880 NW 18TH TERRACE SE DECISION MADE: 14-JUL-04 MIAMI, FL 33172 510(k) STATEMENT DEVICE: MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM AGA-LINDE HEALTH CARE 510(k) NO: K033897(TRADITIONAL) ATTN: JAMES JOCHEN ROGERS PHONE NO : 440-546-4936 P.O. BOX 391117 SE DECISION MADE: 19-JUL-04 SOLON, OH 44139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM AGFA CORP. 510(k) NO: K041701(SPECIAL) ATTN: JEFFERY A JEDLICKA PHONE NO : 864-421-1815 10 SOUTH ACADEMY ST. SE DECISION MADE: 22-JUL-04 GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K041241(TRADITIONAL) ATTN: STACY L LEWIS PHONE NO : 858-458-7563 10221 WATERIDGE CIR. SE DECISION MADE: 06-JUL-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELIPORT OCCLUDING DEVICE ALCON, INC. 510(k) NO: K040231(TRADITIONAL) ATTN: KIM B KRACKE PHONE NO : 817-551-8338 6201 SOUTH FREEWAY SE DECISION MADE: 13-JUL-04 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM ALOKA CO. LTD USA 510(k) NO: K041916(TRADITIONAL) ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088 10 FAIRFIELD BLVD. SE DECISION MADE: 30-JUL-04 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AMBU DISPOSABLE PRESSURE MANOMETER AMBU, INC. 510(k) NO: K040991(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-636-1144 611 NORTH HAMMONDS FERRY ROAD SE DECISION MADE: 22-JUL-04 LINTHICUM, MD 21090-1356 510(k) STATEMENT DEVICE: AMERICAN BANTEX MS 4 MINI SCOOTER AMERICAN BANTEX CORP. 510(k) NO: K040754(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-295-0748 994 NORTH MAIN STREET SE DECISION MADE: 23-JUL-04 BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054 ANALOGIC CORP. 510(k) NO: K041376(ABBREVIATED) ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 20-JUL-04 PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K041420(TRADITIONAL) ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 26-JUL-04 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: APEX MEDICAL CPAP MODEL 9S-003 APEX MEDICAL CORP. 510(k) NO: K041828(SPECIAL) ATTN: ALAN CHANG PHONE NO : 886 2 22683100 NO. 9, MINSHENG STREET SE DECISION MADE: 30-JUL-04 TUCHENG CITY, TAIPEI COUNTY, CHINA510(k) STATEMENT DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K041745(TRADITIONAL) ATTN: LINGA SUMARTA PHONE NO : 62 21 7243535 128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 15-JUL-04 MANSYUR 510(k) STATEMENT JAKARTA BARAT, INDONESIA 11210 DEVICE: SHARPSAWAY II LOCKING DISPOSABLE CUP ARROW INTL., INC. 510(k) NO: K041153(TRADITIONAL) ATTN: ELIZABETH PRICE PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 12-JUL-04 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX SMALL FRAGMENT PLATES AND SCREWS ARTHREX, INC. 510(k) NO: K040907(TRADITIONAL) ATTN: SALLY FOUST PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 01-JUL-04 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESORBABLE INTERFERENCE SCREW ARTHROTEK, INC. 510(k) NO: K041274(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 28-JUL-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIB ASAHI MEDICAL CO., LTD. 510(k) NO: K041726(SPECIAL) ATTN: DAVID L WEST PHONE NO : 301-272-3113 1801 ROCKVILLE PIKE PIKE SE DECISION MADE: 23-JUL-04 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: BIS PEDIATRIC SENSOR ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K041670(SPECIAL) ATTN: RENEE GOULD PHONE NO : 617-559-7788 141 NEEDHAM ST. SE DECISION MADE: 06-JUL-04 NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATRICURE DISSECTOR ATRICURE, INC. 510(k) NO: K041681(TRADITIONAL) ATTN: MARK JOB PHONE NO : 763-682-4139 6033 SCHUMACHER PARK DR. SE DECISION MADE: 01-JUL-04 WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) BAUSCH & LOMB 510(k) NO: K040913(TRADITIONAL) ATTN: DAVID THOMAS PHONE NO : 909-971-5104 180 VIA VERDE DRIVE SE DECISION MADE: 23-JUL-04 SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BAWMED RESCUE MASK BAWMED UK 510(k) NO: K031431(TRADITIONAL) ATTN: BARBARA WOODS PHONE NO : 44 144 6794567 6 GREAT HOUSE MEADOWS SE DECISION MADE: 13-JUL-04 UNITED KINGDOM, UNITED KINGDOM CF6510(k) STATEMENT DEVICE: BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUM BAXTER HEALTHCARE CORPORATION 510(k) NO: K041738(SPECIAL) ATTN: KAREN SPRANGER PHONE NO : 847-270-5426 ROUTE 120 AND WILSON RD. SE DECISION MADE: 09-JUL-04 ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE BAYER HEALTHCARE, LLC 510(k) NO: K041133(SPECIAL) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 02-JUL-04 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK WHOLE BLOOD VOLATILES CONTROL BIO-RAD 510(k) NO: K041561(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 06-JUL-04 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIMUS OS (OVERDENTURE SYSTEM) BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K041938(SPECIAL) ATTN: WINSTON GREER PHONE NO : 205-967-7880 ONE PERIMETER PARK SOUTH SE DECISION MADE: 22-JUL-04 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-0 BIOJECT MEDICAL TECHNOLOGIES INC. 510(k) NO: K041564(TRADITIONAL) ATTN: LAURENCE A POTTER PHONE NO : 908-470-2800 211 SOMERVILLE ROAD SE DECISION MADE: 16-JUL-04 BEDMINSTER, NJ 07921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATERLASE BIOLASE TECHNOLOGY, INC. 510(k) NO: K031140(TRADITIONAL) ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200 981 CALLE AMANECER SE DECISION MADE: 07-JUL-04 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K040007(TRADITIONAL) ATTN: RICHARD SAXON PHONE NO : 760-727-5600 2448 CADES WAY SE DECISION MADE: 07-JUL-04 P.O. BOX 1360 510(k) STATEMENT VISTA, CA 92085-1360 DEVICE: TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) BIOMET MANUFACTURING CORP. 510(k) NO: K041466(SPECIAL) ATTN: TRACY J BICKEL, RAC PHONE NO : 574-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 01-JUL-04 WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMEN SURGICAL NAVIGATION SYSTEM BIOMET, INC. 510(k) NO: K031454(TRADITIONAL) ATTN: KRISTINE C ARNOLD PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 08-JUL-04 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM BIOMET, INC. 510(k) NO: K041352(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 30-JUL-04 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICAT BIOSITE INCORPORATED 510(k) NO: K040459(TRADITIONAL) ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 06-JUL-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPORE BALLOON DILATION CATHETER BIPORE, INC. 510(k) NO: K041293(ABBREVIATED) ATTN: KEITH PALUCH PHONE NO : 201-767-1993 31 INDUSTRIAL PKWY. SE DECISION MADE: 09-JUL-04 NORTHVALE, NJ 07647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIPHERAL CUTTING BALLOON BOSTON SCIENTIFIC CORP. 510(k) NO: K040155(TRADITIONAL) ATTN: RENUKA KRISHNAN PHONE NO : 858-268-4488 3574 RUFFIN ROAD SE DECISION MADE: 01-JUL-04 SAN DIEGO, CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRACTOR RX RETRIEVAL BALLOON BOSTON SCIENTIFIC CORP. 510(k) NO: K041606(SPECIAL) ATTN: JAMES D MCMAHON PHONE NO : 508-652-5566 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 07-JUL-04 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTFE FELTS AND PLEDGETS BOSTON SCIENTIFIC CORP. 510(k) NO: K041716(SPECIAL) ATTN: MAUREEN MONTBRIAND PHONE NO : 763-494-2903 TWO SCIMED PLACE SE DECISION MADE: 22-JUL-04 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K041727(SPECIAL) ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307 47900 BAYSIDE PKWY. SE DECISION MADE: 23-JUL-04 FREEMONT, CA 94538 510(k) STATEMENT DEVICE: PATXFER RT BRAINLAB, AG 510(k) NO: K040931(TRADITIONAL) ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 AMMERTHALSTRASSE 8 SE DECISION MADE: 22-JUL-04 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOURCELINK C.R. BARD, INC. 510(k) NO: K041576(SPECIAL) ATTN: JOHN C KNORPP PHONE NO : 770-784-6451 8195 INDUSTRIAL BLVD. SE DECISION MADE: 02-JUL-04 COVINGTON, GA 30014-2655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAVOL DELIVERY SYSTEM C.R. BARD, INC. 510(k) NO: K041641(TRADITIONAL) ATTN: SUZANNE LASCALZA PHONE NO : 401-463-7000 100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 01-JUL-04 P.O. BOX 8500 510(k) SUMMARY AVAILABLE FROM FDA CRANSTON, RI 02920 THIRD PARTY REVIEW DEVICE: EASYNET BODY POSITION MODULE CADWELL LABORATORIES, INC. 510(k) NO: K040932(TRADITIONAL) ATTN: CHRIS BOLKAN PHONE NO : 509-735-6481 909 NORTH KELLOGG ST. SE DECISION MADE: 01-JUL-04 KENNEWICK, WA 99336 510(k) STATEMENT DEVICE: CADWELL LIMB MOVEMENT MODULE CADWELL LABORATORIES, INC. 510(k) NO: K040986(TRADITIONAL) ATTN: CHRIS BOLKAN PHONE NO : 509-735-6481 909 NORTH KELLOGG ST. SE DECISION MADE: 01-JUL-04 KENNEWICK, WA 99336 510(k) STATEMENT DEVICE: CRONO AND CRONO, MODEL 30 CANE S.R.L. 510(k) NO: K041414(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 08-JUL-04 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DA CANTOR & NISSEL LTD. 510(k) NO: K041700(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DR. SE DECISION MADE: 30-JUL-04 GRAND JUCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERHEART AED G3A CARDIAC SCIENCE, INC. 510(k) NO: K040438(TRADITIONAL) ATTN: KENNETH OLSON PHONE NO : 952-939-2912 5474 FELTL RD. SE DECISION MADE: 01-JUL-04 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGENMD CARDIOVASCULAR IMAGING TECHNOLOGIE510(k) NO: K041671(TRADITIONAL) ATTN: MALINIE HASEK PHONE NO : 816-347-9224 200 N.E. MULBERRY SE DECISION MADE: 22-JUL-04 LEE'S SUMMIT, MO 64086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPSIOS BONE VOID FILLER (BVF) CENTERPULSE SPINE-TECH, INC. 510(k) NO: K033679(TRADITIONAL) ATTN: TIM MILLER PHONE NO : 952-830-6284 7375 BUSH LAKE RD. SE DECISION MADE: 07-JUL-04 MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAGEM-C THERMAL ACUPRESSURE MASSAGER CERAGEM CO., LTD. 510(k) NO: K040031(TRADITIONAL) ATTN: SUZAN ONEL PHONE NO : 202-778-9134 1800 MASSACHUSETTS AVE., NW SE DECISION MADE: 28-JUL-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036-1221 DEVICE: AOC BONE WAX CEREMED INC. 510(k) NO: K041363(TRADITIONAL) ATTN: TADEUSZ WEKKUSZ MD PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 27-JUL-04 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DDS-ZR CHARLES SCHARF 510(k) NO: K041645(TRADITIONAL) ATTN: CHRIS SCHARF PHONE NO : 720-435-9052 7375 S. PEORIA ST. #105 B-10 SE DECISION MADE: 09-JUL-04 ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYGEN MEDICELS, CITICELS CITY TECHNOLOGY LIMITED 510(k) NO: K041773(TRADITIONAL) ATTN: DEBRA WALLACE PHONE NO : WALTON ROAD SE DECISION MADE: 15-JUL-04 PORTSMOUTH,HAMPSHIRE ENGLAND, UNIT510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REPROCESSED SURGICAL SCISSORS AND GRASPERS CLEAR MEDICAL, INC. 510(k) NO: K033592(TRADITIONAL) ATTN: MIKE KOVACS PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 27-JUL-04 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMI MAGNETOCARDIOGRAPH CMI CARDIOMAG IMAGING INC 510(k) NO: K033488(TRADITIONAL) ATTN: STEVEN KARR PHONE NO : 518-381-1000 450 DUANE AVE. SE DECISION MADE: 07-JUL-04 SCHENECTADY, NY 12304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADSTREAM VERSION 3.1 CONFIRMA, INC. 510(k) NO: K041020(TRADITIONAL) ATTN: PATRICIA A MILBANK PHONE NO : 425-894-9733 821 KIRKLAND AVE. SE DECISION MADE: 07-JUL-04 KIRKLAND, WA 98033-6318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET COOK, INC. 510(k) NO: K041044(TRADITIONAL) ATTN: JENNIFER BOSLEY PHONE NO : 812-339-2235 750 DANIELS WAY SE DECISION MADE: 29-JUL-04 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS COOPERVISION, INC. 510(k) NO: K041138(TRADITIONAL) ATTN: BONNIE J TSYMBAL PHONE NO : 585-264-3210 711 NORTH RD. SE DECISION MADE: 23-JUL-04 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS DADE BEHRING, INC. 510(k) NO: K041150(TRADITIONAL) ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183 1584 ENTERPRISE BLVD. SE DECISION MADE: 22-JUL-04 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBN DADE BEHRING, INC. 510(k) NO: K041417(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 20-JUL-04 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: N APOLIPOPROTEIN STANDARD SERUM DADE BEHRING, INC. 510(k) NO: K041870(TRADITIONAL) ATTN: DONNA A WOLF PHONE NO : 302-631-0384 514 GBC DR. SE DECISION MADE: 27-JUL-04 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIO MONITOR DATASCOPE CORP. 510(k) NO: K041907(ABBREVIATED) ATTN: SUSAN E MANDY PHONE NO : 201-995-8025 800 MACARTHUR BLVD. SE DECISION MADE: 23-JUL-04 MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACC DATEX-OHMEDA 510(k) NO: K041772(SPECIAL) ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 28-JUL-04 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LC DATEX-OHMEDA 510(k) NO: K041790(TRADITIONAL) ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 23-JUL-04 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTIUM CO., LTD. IMPLANTIUM DENTIUM CO., LTD. 510(k) NO: K041368(ABBREVIATED) ATTN: CATHRYN N CAMBRIA PHONE NO : 404-543-5909 5536 TROWBRIDGE DRIVE SE DECISION MADE: 29-JUL-04 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERCON CERAM EXPRESS CERAMIC SYSTEM DENTSPLY INTL. 510(k) NO: K041707(SPECIAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 30-JUL-04 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) DEPUY ORTHOPAEDICS, INC. 510(k) NO: K040281(TRADITIONAL) ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905 700 ORTHOPAEDIC DR. SE DECISION MADE: 09-JUL-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV DEPUY ORTHOPAEDICS, INC. 510(k) NO: K041656(SPECIAL) ATTN: TIFFANI ROGERS PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 01-JUL-04 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K041119(SPECIAL) ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867 325 PARAMOUNT DR. SE DECISION MADE: 19-JUL-04 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LPS DEPUY, INC. 510(k) NO: K033959(TRADITIONAL) ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905 P.O. BOX 988 SE DECISION MADE: 01-JUL-04 700 ORTHOPAEDIC DRIVE 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCAL DEPUY, INC. 510(k) NO: K041085(TRADITIONAL) ATTN: TIFFANI ROGERS PHONE NO : 574-371-4927 P.O. BOX 988 SE DECISION MADE: 22-JUL-04 700 ORTHOPAEDIC DRIVE 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER DEROYAL 510(k) NO: K041416(ABBREVIATED) ATTN: SHARON COOK PHONE NO : 865-938-7828 200 DEBUSK LN. SE DECISION MADE: 02-JUL-04 POWELL, TN 37849 510(k) STATEMENT DEVICE: DIAPHARMA FACTOR X KIT DIAPHARMA GROUP, INC. 510(k) NO: K040362(TRADITIONAL) ATTN: JENNIFER J KIBLINGER PHONE NO : 513-860-9324 8948 BECKETT RD. SE DECISION MADE: 12-JUL-04 WEST CHESTER, OH 45069 510(k) STATEMENT DEVICE: TSH-CTK-3 IRMA DIASORIN, INC. 510(k) NO: K041014(TRADITIONAL) ATTN: DAVID M IKEDA PHONE NO : 651-351-5592 1951 NORTHWESTERN AVE. SE DECISION MADE: 14-JUL-04 P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA STILLWATER, MN 55082 DEVICE: 3DSCOPE DIREX SYSTEMS CORP. 510(k) NO: K041213(SPECIAL) ATTN: LARISA GERSHTEIN PHONE NO : 508-651-0900 11 MERCER RD. SE DECISION MADE: 22-JUL-04 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TRIPTER X-1 COMPACT DUET DIREX SYSTEMS CORP. 510(k) NO: K041582(SPECIAL) ATTN: LARISA GERSHTEIN PHONE NO : 508-651-0900 11 MERCER RD. SE DECISION MADE: 07-JUL-04 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHE DRAEGER MEDICAL, INC. 510(k) NO: K041622(SPECIAL) ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 08-JUL-04 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPOWER TRANSFER SET, (CAT. NO. 7725) E-Z-EM, INC. 510(k) NO: K041178(TRADITIONAL) ATTN: JUDY HAUSER PHONE NO : 516-333-8230 717 MAIN ST. SE DECISION MADE: 16-JUL-04 WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI XFIX DFS SYSTEM EBI, L.P. 510(k) NO: K040935(TRADITIONAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 06-JUL-04 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULA EDWARDS LIFESCIENCES LLC. 510(k) NO: K033463(TRADITIONAL) ATTN: JASON SMITH PHONE NO : 949-250-2662 ONE EDWARDS WAY SE DECISION MADE: 28-JUL-04 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPAT ELEKON INDUSTRIES U.S.A., INC. 510(k) NO: K041644(TRADITIONAL) ATTN: KRISTA OAKES PHONE NO : 972-849-5167 2300 MCDERMOTT RD. SE DECISION MADE: 29-JUL-04 #200-207 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75025 DEVICE: ELEKTA MICRODRIVE, MODEL 916716 ELEKTA INSTRUMENT AB 510(k) NO: K040979(TRADITIONAL) ATTN: ANDERS SKOGLUND PHONE NO : 011 468 58725400 KUNGSTENSGATAN 18 SE DECISION MADE: 23-JUL-04 PO BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA STOCKHOLM, SWEDEN S-103 93 DEVICE: 3DKNEE POROUS COATED FEMORAL COMPONENT ENCORE ORTHOPEDICS, INC. 510(k) NO: K032905(TRADITIONAL) ATTN: KIMBERLY L PRUITT PHONE NO : 512-834-6291 9800 METRIC BLVD. SE DECISION MADE: 06-JUL-04 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARILUX VISIONPRINT SYSTEM (VPS) ESSILOR INTL. 510(k) NO: K033949(TRADITIONAL) ATTN: MARC J SCHEINESON PHONE NO : 202-414-9243 1301 K STREET, NW SE DECISION MADE: 02-JUL-04 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE EST INTERNATIONAL CORPORATION 510(k) NO: K041325(TRADITIONAL) ATTN: ELIZABETH DENG PHONE NO : 909-465-9188 7668 BELPINE PLACE SE DECISION MADE: 02-JUL-04 RANCHO CUCAMONGA, CA 91730 510(k) STATEMENT DEVICE: COBRA ADHERE SURGICAL SYSTEM ESTECH, INC. 510(k) NO: K041599(TRADITIONAL) ATTN: CRAIG COOMBS PHONE NO : 650-380-2474 2029 ALAMEDA AVE. SE DECISION MADE: 27-JUL-04 ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUSURE BLOOD GLUCOSE MONITORING SYSTEM EUMED BIOTECHNOLOGY CO., LTD. 510(k) NO: K040678(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 14-JUL-04 HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FENZIAN TREATMENT SYSTEM EUMEDIC LIMITED 510(k) NO: K041575(TRADITIONAL) ATTN: LEWIS W WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 16-JUL-04 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE EUROPEAN CUSTOM MANUFACTURING BV 510(k) NO: K033858(TRADITIONAL) ATTN: MAARTEN KANTERS PHONE NO : 716-626-4378 OOST-OM 54 SE DECISION MADE: 12-JUL-04 NL-5422 VZ 510(k) STATEMENT GEMERT, NETHERLANDS DEVICE: ARCHITECT STAT CK-MB IMMUNOASSAY FISHER DIAGNOSTICS 510(k) NO: K041596(TRADITIONAL) ATTN: JOSEFINA INFANTAS PHONE NO : 540-869-8158 8365 VALLEY PIKE, PO BX 307 SE DECISION MADE: 21-JUL-04 MIDDLETOWN, VA 22645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FS SERIES WHEELCHAIR FOSHAN DONGFANG MEDICAL EQUIPMENT 510(k) NO: K041814(TRADITIONAL) ATTN: PANG JIANXUN PHONE NO : 86 757 86299415 2 BAOHUA INDUSTRIAL PARK AV. SE DECISION MADE: 20-JUL-04 GUILAN RD. NANHAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA FOSHAN, GUANGDONG PROVINCE, CHINA THIRD PARTY REVIEW DEVICE: SPLIT SEPTUM INJECTION SITES FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K041042(SPECIAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 16-JUL-04 LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANKYLOS DENTAL IMPLANT SYSTEM FRIADENT GMBH 510(k) NO: K040946(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 01-JUL-04 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ 7 ULTRASOUND BT04 GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K041813(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 23-JUL-04 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE SIGNA PROFILE 6 INCH GP COIL GE MEDICAL SYSTEMS, LLC 510(k) NO: K041921(SPECIAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 PO BOX 414 SE DECISION MADE: 26-JUL-04 W-400 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53201 DEVICE: VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 GEISTER MEDIZINTECHNIK GMBH 510(k) NO: K022823(TRADITIONAL) ATTN: DAGMAR MASER PHONE NO : 828-622-7572 152B BRIDGE ST. SE DECISION MADE: 01-JUL-04 HOT SPRINGS, NC 28743 510(k) STATEMENT DEVICE: GE VIVID 7 BT04 GENERAL ELECTRIC CO. 510(k) NO: K041552(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 4855 WEST ELECTRIC AVENUE SE DECISION MADE: 02-JUL-04 PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53219 DEVICE: GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 GENERAL ELECTRIC CO. 510(k) NO: K041688(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 4855 WESTELECTRIC AVENUE SE DECISION MADE: 08-JUL-04 PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53219 DEVICE: GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR GENERAL ELECTRIC CO. 510(k) NO: K041922(SPECIAL) ATTN: DAVID DUERSTELER PHONE NO : 262-312-7029 P.O. BOX 414 SE DECISION MADE: 28-JUL-04 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/ GENESIS MEDICAL INTERVENTIONAL, IN510(k) NO: K040010(TRADITIONAL) ATTN: ANNE WORDEN PHONE NO : 650-367-7667 652 BAIR ISLAND ROAD SE DECISION MADE: 19-JUL-04 SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA REDWOOD CITY, CA 94063 DEVICE: FERTELL MALE FERTILITY TEST GENOSIS LTD. 510(k) NO: K041039(TRADITIONAL) ATTN: SHARON A SEGAL PHONE NO : 202-739-5427 1111 PENNSYLVANIA AVE. N.W. SE DECISION MADE: 20-JUL-04 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GETTIG UNIVERSAL VIAL ACCESS PIN GETTIG PHARMACEUTICAL INSTRUMENT C510(k) NO: K041232(TRADITIONAL) ATTN: JAMES A BENZ PHONE NO : 814-422-8892 ONE STREAMSIDE PL. WEST SE DECISION MADE: 22-JUL-04 SPRING MILLS, PA 16875-0085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K040682(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 714-990-6888 590 W. CENTRAL AVE., #D SE DECISION MADE: 28-JUL-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K041225(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 714-990-6888 590 W. CENTRAL AVE., #D SE DECISION MADE: 15-JUL-04 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDANT MAZE SYSTEM AND MICROWAVE PROBE SET GUIDANT CARDIAC SURGERY 510(k) NO: K041340(TRADITIONAL) ATTN: NANCY GALLO PHONE NO : 408-845-2006 3200 LAKESIDE DR. SE DECISION MADE: 28-JUL-04 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 GUIDANT CORPORATION 510(k) NO: K041574(SPECIAL) ATTN: AMITA SHENAI PHONE NO : 651-582-6306 4100 HAMLINE AVE NORTH SE DECISION MADE: 12-JUL-04 ST PAUL, MN 55112-5798 510(k) STATEMENT DEVICE: H&S-CONDUCTIVITY; STANDARD SOLUTION H & S TECHNICAL SERVICES 510(k) NO: K041636(TRADITIONAL) ATTN: JOHN HYTE PHONE NO : 480-517-4918 1833 W. MAIN STREET STE. 119 SE DECISION MADE: 02-JUL-04 MESA, AZ 85201 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES HAND INNOVATIONS, INC. 510(k) NO: K041081(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 8905 SW 87TH AVE. SE DECISION MADE: 01-JUL-04 MIAMI, FL 33176-2227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SMALL BONE FIXATION SYSTEM HAND INNOVATIONS, INC. 510(k) NO: K041157(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 8905 SW 87TH AVE. SE DECISION MADE: 30-JUL-04 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33176-2227 DEVICE: FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD 510(k) NO: K041391(TRADITIONAL) ATTN: TITO ALDAPE PHONE NO : 775-746-6600 2301 ROBB DR. SE DECISION MADE: 09-JUL-04 RENO, NV 89523 510(k) STATEMENT DEVICE: MODIFICATION TO ENCOMPASS HEARTLAB, INC. 510(k) NO: K040896(TRADITIONAL) ATTN: RICHARD PETROCELLI PHONE NO : 401-596-0592 1 CROSSWIND RD. SE DECISION MADE: 16-JUL-04 WESTERLY, RI 02891 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUILE OINTMENT WOUND DRESSING HEDONIST BIOCHEMICAL TECHNOLOGIES 510(k) NO: K041013(TRADITIONAL) ATTN: ERIC LUO, PH.D. PHONE NO : 214 243 8218 6F, NO. 208, RUEI-GUANG ROAD SE DECISION MADE: 07-JUL-04 TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT DEVICE: OMEGA 2 SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K041001(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 01-JUL-04 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROJET XT HYDROCISION, INC. 510(k) NO: K041233(SPECIAL) ATTN: DEBBIE IMAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 28-JUL-04 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN IBL GMBH 510(k) NO: K040923(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570-620-0198 150 CHERRY LANE RD. SE DECISION MADE: 22-JUL-04 EAST STROUDSBURG, PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) IBT SA 510(k) NO: K041702(SPECIAL) ATTN: RUTH FEICHT PHONE NO : 770-582-0662 6000 LIVE OAK PARKWAY, STE 107 SE DECISION MADE: 16-JUL-04 NORCROSS, GA 30093 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 ICU MEDICAL INC 510(k) NO: K041410(TRADITIONAL) ATTN: DALE FAIRCHILD PHONE NO : 860-870-6112 129 RESERVOIR RD. SE DECISION MADE: 28-JUL-04 VERNON, CT 06066-5705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX IMAGE ANALYSIS, INC. 510(k) NO: K040782(TRADITIONAL) ATTN: BEN ARNOLD PHONE NO : 270-384-6400 1380 BURKESVILLE ST. SE DECISION MADE: 13-JUL-04 COLUMBIA, KY 42728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX IMPLEX CORP. 510(k) NO: K040756(SPECIAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 14-JUL-04 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDIACOLON INFINITT CO., LTD. 510(k) NO: K041761(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 904-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 13-JUL-04 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACNELIFT INNER ACT, LLC 510(k) NO: K041103(TRADITIONAL) ATTN: RONNIE LAMBERTON PHONE NO : 775-829-2566 4750 TURBO CIRCLE SE DECISION MADE: 27-JUL-04 RENO, NV 89502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEEK CEMENT RESTRICTOR "X-BOX" INNOVASIS, INC. 510(k) NO: K041583(TRADITIONAL) ATTN: BRENT A FELIX PHONE NO : 801-557-1445 997 EAST 3900 SOUTH SE DECISION MADE: 22-JUL-04 SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA SALT LAKE CITY, UT 84124 DEVICE: NEURA WRAP NERVE PROTECTOR INTEGRA LIFESCIENCES CORP. 510(k) NO: K041620(TRADITIONAL) ATTN: DIANA M BORDON PHONE NO : 609-275-0500 311 ENTERPRISE DR. SE DECISION MADE: 16-JUL-04 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M'ATH STD INTELLIGENCE IN MEDICAL TECHNOLOGI510(k) NO: K040686(TRADITIONAL) ATTN: SCOTT PEASE PHONE NO : 414-704-6979 P.O. BOX 222 SE DECISION MADE: 30-JUL-04 HARTLAND, WI 53029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTISOURCE, MODEL 1032P INTERNATIONAL BRACHYTHERAPY S.A. 510(k) NO: K040766(TRADITIONAL) ATTN: RUTH FEICHT PHONE NO : 770-582-0662 6000 LIVE OAK PARKWAY SE DECISION MADE: 22-JUL-04 SUITE 107 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30093 DEVICE: SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLA INTERPORE CROSS INTL. 510(k) NO: K041449(SPECIAL) ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 01-JUL-04 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM INTERPORE CROSS INTL. 510(k) NO: K041794(SPECIAL) ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 19-JUL-04 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM INTUITIVE SURGICAL, INC. 510(k) NO: K040237(TRADITIONAL) ATTN: USHA KREADEN PHONE NO : 408-523-2140 950 KEFER RD. SE DECISION MADE: 07-JUL-04 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPEN BORE SYRINGE ISOTIS NV 510(k) NO: K041344(ABBREVIATED) ATTN: ELIANE SCHUTTE PHONE NO : 31 30 2995253 PROF. BRONKHORSTLAAN 10-D SE DECISION MADE: 16-JUL-04 P.O. BOX 98,3723 AB 510(k) SUMMARY AVAILABLE FROM FDA BILTHOVEN, NETHERLANDS 3723MB DEVICE: JMS ABSORBABLE ANCHOR AND APPLICATOR JMS, INC. 510(k) NO: K041159(TRADITIONAL) ATTN: JOHN I SHIPP PHONE NO : 904-641-2599 1221 1ST STREET SOUTH SE DECISION MADE: 27-JUL-04 # 7A 510(k) STATEMENT JACKSONVILLE BEACH, FL 32250 DEVICE: ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER JOHN MFG., LTD. 510(k) NO: K033448(TRADITIONAL) ATTN: ARTHUR KING MA PHONE NO : 626-581-1290 18780 AMAR ROAD, STE 203-203 SE DECISION MADE: 12-JUL-04 WALNUT, CA 91789 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAPP CUSTOM ULNAR HEAD WRIST IMPLANT KAPP SURGICAL INSTRUMENT, INC. 510(k) NO: K033930(TRADITIONAL) ATTN: ALBERT SANTILLI PHONE NO : 216-587-4400 4919 WARRENSVILLE CENTER RD. SE DECISION MADE: 28-JUL-04 WARRENSVILLE HEIGHTS, OH 44128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARMA POWER WHEELCHAIR, MODEL KP-25 KARMA MEDICAL PRODUCTS CO., LTD. 510(k) NO: K041678(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 23-JUL-04 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES KERBEROS PROXIMAL SOLUTIONS, INC. 510(k) NO: K041151(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 925-254-5228 1400 TERRA BELLA AVE, SUITE K SE DECISION MADE: 22-JUL-04 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A KYPHON, INC. 510(k) NO: K041454(TRADITIONAL) ATTN: CINDY DOMESCUS PHONE NO : 408-222-6740 1221 CROSSMAN AVE. SE DECISION MADE: 09-JUL-04 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYPHX HV-R BONE CEMENT, MODEL C01A KYPHON, INC. 510(k) NO: K041584(TRADITIONAL) ATTN: CINDY DOMECUS PHONE NO : 408-222-6740 1221 CROSSMAN AVE. SE DECISION MADE: 07-JUL-04 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTCA STEERABLE HYDROPHILIC GUIDEWIRE LAKE REGION MFG., INC. 510(k) NO: K041624(SPECIAL) ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111 340 LAKE HAZELTINE DR. SE DECISION MADE: 16-JUL-04 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NASALCEASE LES LABORATORIES, S.A. 510(k) NO: K041446(TRADITIONAL) ATTN: RICHARD J FREER, PH.D. PHONE NO : 804-648-3820 601 BIOTECH DRIVE SE DECISION MADE: 01-JUL-04 RICHMOND, VA 23235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE, LLC. 510(k) NO: K040844(TRADITIONAL) ATTN: MICHAEL S BUTLER PHONE NO : 317-826-7006 11965 EAST 65TH ST. SUITE 4 SE DECISION MADE: 23-JUL-04 INDIANAPOLIS, IN 46236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER LIFECORE BIOMEDICAL, INC. 510(k) NO: K041324(TRADITIONAL) ATTN: KIM E AVES PHONE NO : 952-368-6324 3515 LYMAN BLVD. SE DECISION MADE: 19-JUL-04 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUTURE ARROW LINVATEC CORP. 510(k) NO: K041128(TRADITIONAL) ATTN: ELIZABETH M PAUL PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 29-JUL-04 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER REVO HERCULINE SUTURE ANCHOR LINVATEC CORP. 510(k) NO: K041713(SPECIAL) ATTN: ELIZABETH M PAUL PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 22-JUL-04 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACROPORE HYDROSORB SPINE SYSTEM MACROPORE BIOSURGERY, INC. 510(k) NO: K041105(TRADITIONAL) ATTN: KENNETH KLEINHENZ PHONE NO : 858-458-0900 6740 TOP GUN ST. SE DECISION MADE: 28-JUL-04 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOODKNIGHT 425, MODELM-114500-00 MALLINCKRODT DEVELOPPEMENT FRANCE 510(k) NO: K041819(SPECIAL) ATTN: JAMES BONDS PHONE NO : 925-463-4371 4280 HACIENDA DR. SE DECISION MADE: 22-JUL-04 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MANUFACTURING TECHNOLOGY, INC. 510(k) NO: K040554(ABBREVIATED) ATTN: JOHN G SCHNEIDER PHONE NO : 850-244-7211 70 READY AVE., N.W. SE DECISION MADE: 16-JUL-04 FORT WALTON BEACH, FL 32548 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROMESAM BASIC-SET MAP MEDIZINTECHNIK FUR ARZT UND PA510(k) NO: K040576(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2282 14040 DANIELSON ST. SE DECISION MADE: 01-JUL-04 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E MAQUET CRITICAL CARE AB 510(k) NO: K041223(TRADITIONAL) ATTN: JAMIE YIEH PHONE NO : 908-947-2311 1140 ROUTE 22 EAST SE DECISION MADE: 29-JUL-04 SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA BRIDGEWATER, NJ 08807 DEVICE: LNCS OXIMETRY SENSORS MASIMO CORP. 510(k) NO: K041815(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-279-7000 40 PARKER SE DECISION MADE: 29-JUL-04 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES MED2000 SPA 510(k) NO: K041327(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., STE 200 SE DECISION MADE: 20-JUL-04 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDCOMMONS OPEN RADIOLOGY GATEWAY MEDCOMMONS, INC. 510(k) NO: K041326(ABBREVIATED) ATTN: CHAS BURR PHONE NO : 781-789-1646 11 MYSTIC AVENUE SE DECISION MADE: 27-JUL-04 WINCHESTER, MA 01890-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 MEDCOMP 510(k) NO: K040992(TRADITIONAL) ATTN: JEAN CALLOW PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 29-JUL-04 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRO MEDICAL ADHESIVEONLINE, LLC. 510(k) NO: K041101(TRADITIONAL) ATTN: ADAM SHAW PHONE NO : 614-323-0672 10809 GARDEN MIST SE DECISION MADE: 07-JUL-04 #2045 510(k) SUMMARY AVAILABLE FROM FDA LAS VEGAS, NV 89135 DEVICE: QWIKCHECK-BEADS MEDICAL ELECTRONICS SYSTEMS LTD. 510(k) NO: K041600(TRADITIONAL) ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768 575 SHIRLYNN COURT SE DECISION MADE: 27-JUL-04 LOS ALTOS, CA 94022 510(k) STATEMENT DEVICE: LUNG CAR 1.1 MEDICSIGHT 510(k) NO: K041807(SPECIAL) ATTN: CAROL MACDONALD PHONE NO : 44 207 5985351 46 BERKELEY SQUARE SE DECISION MADE: 22-JUL-04 LONDON, UNITED KINGDOM W 1J 5AT 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO-CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K041162(TRADITIONAL) ATTN: J.I. HOLLANDER PHONE NO : 31 71 5223244 SCHUTTERSVELD 9 SE DECISION MADE: 27-JUL-04 LEIDEN, NETHERLANDS 2316 XG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T MEDITEC CO., LTD. 510(k) NO: K041789(TRADITIONAL) ATTN: RONALD D ARKIN PHONE NO : 770-565-6166 1733 CANTON LANE SE DECISION MADE: 15-JUL-04 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES MEDIX, INC. 510(k) NO: K041345(TRADITIONAL) ATTN: BARBARA LAW PHONE NO : 614-889-2220 6250 SHIER RINGS ROAD SE DECISION MADE: 22-JUL-04 DUBLIN, OH 43016 510(k) STATEMENT DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEM MEDLINE INDUSTRIES, INC. 510(k) NO: K040841(TRADITIONAL) ATTN: JENNIFER MASON PHONE NO : 847-949-2670 ONE MEDLINE PLACE SE DECISION MADE: 08-JUL-04 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: LIFEPAK 12 DEFIBRILLATOR/MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTE510(k) NO: K041459(SPECIAL) ATTN: MICHELLE ACKERMANN PHONE NO : 425-867-4744 11811 WILLOWS RD., N.E. SE DECISION MADE: 01-JUL-04 REDMOND, WA 98073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUM MEDTRONIC MINIMED 510(k) NO: K041317(SPECIAL) ATTN: MARK J FAILLACE PHONE NO : 818-362-5958 18000 DEVONSHIRE ST. SE DECISION MADE: 19-JUL-04 NORTHRIDGE, CA 91325-1219 510(k) STATEMENT DEVICE: MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP MEDTRONIC MINIMED 510(k) NO: K041318(SPECIAL) ATTN: MARK J FAILLACE PHONE NO : 818-576-5616 18000 DEVONSHIRE ST. SE DECISION MADE: 19-JUL-04 NORTHRIDGE, CA 91325-1219 510(k) STATEMENT DEVICE: DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY 510(k) NO: K041000(TRADITIONAL) ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR., SE DECISION MADE: 27-JUL-04 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOURGLASS VERTEBRAL BODY SPACER MEDTRONIC SOFAMOR DANEK 510(k) NO: K033926(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 07-JUL-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K041556(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 01-JUL-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K041460(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 01-JUL-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUESTRA FLUID DELIVERY SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K040483(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 23-JUL-04 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPS 3000 SYSTEM MEDTRONIC XOMED, INC. 510(k) NO: K041413(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-434-7487 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 12-JUL-04 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPS 3000 SYSTEM MEDTRONIC XOMED, INC. 510(k) NO: K041523(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-434-7487 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 23-JUL-04 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES MEDTRONIC, INC. 510(k) NO: K041338(TRADITIONAL) ATTN: SCOTT CUNDY PHONE NO : 763-391-9941 7601 NORTHLAND DR. SE DECISION MADE: 19-JUL-04 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERLIN RESUSCITATOR MERLIN MEDICAL LIMITED 510(k) NO: K031395(TRADITIONAL) ATTN: ROGERT STEELE PHONE NO : 004 416 85846663 THE WHITBREAD CENTRE,RHYMNEY, SE DECISION MADE: 16-JUL-04 GWENT 510(k) STATEMENT UNITED KINGDOM, UNITED KINGDOM NP22 5BF DEVICE: MERLIN E-MASK MERLIN MEDICAL LIMITED 510(k) NO: K031397(TRADITIONAL) ATTN: ROBERT STEELE PHONE NO : 440 168 5843676 THE WHITBREAD CENTRE,RHYMNEY, SE DECISION MADE: 29-JUL-04 GWENT 510(k) STATEMENT UNITED KINGDOM, UNITED KINGDOM NP22 5BF DEVICE: SAPPHIRE NXT DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. 510(k) NO: K041649(SPECIAL) ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 16-JUL-04 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFUGE SOUND GENERATOR MICRO-EAR TECHNOLOGY, INC. 510(k) NO: K041302(TRADITIONAL) ATTN: DEBORAH SHAFFER PHONE NO : 763-519-7417 3500 HOLLY LN. NORTH, #10 SE DECISION MADE: 01-JUL-04 PLYMOUTH, MN 55447 510(k) STATEMENT DEVICE: MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP MICROLIFE CORP. 510(k) NO: K041411(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN PHONE NO : 480-451-7502 55 NORTHERN BLVD. SE DECISION MADE: 21-JUL-04 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K041551(SPECIAL) ATTN: VINCENT CUTARELLI PHONE NO : 949-461-3314 75 COLUMBIA SE DECISION MADE: 07-JUL-04 ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIOLASE ND:YAG DENTAL LASER SYSTEM MILLENNIUM DENTAL TECHNOLOGIES, IN510(k) NO: K030290(TRADITIONAL) ATTN: DAVID M HARRIS PHONE NO : 510-583-7574 4256 HEYER AVE. SE DECISION MADE: 26-JUL-04 CASTRO VALLEY, CA 94546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNACAD V1.0 MRI DEVICES CORP. 510(k) NO: K041286(TRADITIONAL) ATTN: TOM TYNES PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 21-JUL-04 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL BBC-127 BIOPSY BREAST COIL MRI DEVICES CORP. 510(k) NO: K041481(SPECIAL) ATTN: THOMAS E TYNES PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 19-JUL-04 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: MYO-TRODE SG DISPOSABLE ELECTRODE MYOTRONICS-NOROMED, INC. 510(k) NO: K040400(TRADITIONAL) ATTN: FRAY ADIB PHONE NO : 206-243-4214 15425 53RD AVE. SOUTH SE DECISION MADE: 20-JUL-04 TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELRONDO DENTAL CERAMIC-ALUMINA NOBEL BIOCARE USA, INC. 510(k) NO: K041312(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-5074 22715 SAVI RANCH PKWY. SE DECISION MADE: 23-JUL-04 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERSEAL NOBLE FIBER TECHNOLOGIES 510(k) NO: K040019(TRADITIONAL) ATTN: PATRICIA DAVIDSON PHONE NO : 877-978-2842 421 S. STATE ST. SE DECISION MADE: 23-JUL-04 CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI TRIGGER GUARD NORTH AMERICAN TECHNICAL SERVICES 510(k) NO: K040439(TRADITIONAL) ATTN: RICHARD LANZILLOTTO PHONE NO : 631-744-0059 30 NORTHPORT ROAD SE DECISION MADE: 08-JUL-04 SOUND BEACH, NY 11789-1734 510(k) STATEMENT DEVICE: MISTIC HUMIDIFICATION SYSTEM NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K033614(TRADITIONAL) ATTN: CASEY KUREK PHONE NO : 847-608-8900 600 CHURCH RD. SE DECISION MADE: 29-JUL-04 ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCENTRA-VISIR NUCLETRON CORP. 510(k) NO: K041719(SPECIAL) ATTN: LISA DIMMICK PHONE NO : 410-312-4100 8671 ROBERT FULTON DRIVE SE DECISION MADE: 22-JUL-04 COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. 510(k) NO: K041424(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4746 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 02-JUL-04 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR652 OLYMPUS AMERICA, INC. 510(k) NO: K041793(SPECIAL) ATTN: BEV HARDING PHONE NO : 972-556-9697 3131 WEST ROYAL LN. SE DECISION MADE: 16-JUL-04 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FO OLYMPUS CORPORATION 510(k) NO: K041494(SPECIAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 01-JUL-04 PO BOX 9058 510(k) SUMMARY AVAILABLE FROM FDA MELVILLE, NY 11747-3157 DEVICE: PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C ON SITE GAS SYSTEMS, INC. 510(k) NO: K041664(TRADITIONAL) ATTN: C. BART GULLONG PHONE NO : 860-667-8888 35 BUDNEY RD. SE DECISION MADE: 29-JUL-04 BUDNEY INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA NEWINGTON,, CT 06111 DEVICE: ORTHOPEDIC ALLIANCE SPINE SYSTEM ORTHOPEDIC ALLIANCE LLC 510(k) NO: K033826(TRADITIONAL) ATTN: ROGER WILLIAMS PHONE NO : 909-304-9001 41558 EASTMAN DRIVE SE DECISION MADE: 01-JUL-04 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA MARIETTA, CA 92562 DEVICE: OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM OSTEOMED L.P. 510(k) NO: K031701(TRADITIONAL) ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600 3885 ARAPAHO RD. SE DECISION MADE: 08-JUL-04 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POCONE INFRARED SPECTROPHOTOMETER OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K041148(TRADITIONAL) ATTN: CYNTHIA A SINCLAIR, RAC PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 15-JUL-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRCON-F PROPHYLAXIS PASTE PASCAL CO., INC. 510(k) NO: K040988(TRADITIONAL) ATTN: VINCENT M TENTARELLI PHONE NO : 425-602-3633 2929 N.E. NORTHUP WAY SE DECISION MADE: 07-JUL-04 BELLEVUE, WA 98004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L1-PRO SYSTEM PELIKAN TECHNOLOGIES, INC 510(k) NO: K041665(TRADITIONAL) ATTN: JACK S GREEN PHONE NO : 650-842-1029 1072 EAST MEADOW CIRCLE SE DECISION MADE: 23-JUL-04 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K041043(TRADITIONAL) ATTN: MICHAEL LINSS PHONE NO : 497 614 7805310 MUNZINGER STRASSE 7 SE DECISION MADE: 02-JUL-04 FREIBURG, GERMANY 79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT PHILIPS MEDICAL SYSTEMS 510(k) NO: K041674(SPECIAL) ATTN: J.P. OUELLETTE PHONE NO : 978-659-4308 3000 MINUTEMAN RD. SE DECISION MADE: 19-JUL-04 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLURA XPER FD10 PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K041949(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 30-JUL-04 P.O. BOX 3003, MS 915 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 DEVICE: PANORAMA 1.0T PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K041602(TRADITIONAL) ATTN: JOSEPH S ARNAUDO PHONE NO : 425-482-8958 22100 BOTHELL EVERETT HWY SE DECISION MADE: 26-JUL-04 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 DEVICE: GEMINI PET/CT IMAGING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K041955(TRADITIONAL) ATTN: RAE ANN FARROW PHONE NO : 440-483-2647 595 MINER RD. SE DECISION MADE: 29-JUL-04 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4 PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K041741(SPECIAL) ATTN: BARRY WYSHOGROD PHONE NO : 978-659-7383 3000 MINUTEMAN RD. SE DECISION MADE: 21-JUL-04 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 PHILIPS ORAL HEALTHCARE, INC. 510(k) NO: K040416(TRADITIONAL) ATTN: ROSE DEGIACOMO PHONE NO : 425-396-2308 35301 S.E. CENTER ST. SE DECISION MADE: 02-JUL-04 SNOQUALMIE, WA 98065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376A DEVICELINK SYSTEM PHILLIPS MEDICAL SYSTEMS 510(k) NO: K041942(SPECIAL) ATTN: HERBERT VAN DYK PHONE NO : 978-659-7383 HEWLETT PACKARD STR. 2 SE DECISION MADE: 23-JUL-04 BOBLINGEN, GERMANY D71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSICIAN INDUSTRIES' DURAMETER SYRINGE PHYSICIAN INDUSTRIES, INC. 510(k) NO: K033739(TRADITIONAL) ATTN: BRIAN BAKER PHONE NO : 801-886-9505 2203 WEST ALEXANDER SE DECISION MADE: 12-JUL-04 SALT LAKE CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE PHYSICIAN INDUSTRIES, INC. 510(k) NO: K040565(TRADITIONAL) ATTN: BRIAN BAKER PHONE NO : 801-886-9505 3395 WEST 1820 SOUTH SE DECISION MADE: 22-JUL-04 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS PIE MEDICAL 510(k) NO: K041675(TRADITIONAL) ATTN: CARRI GRAHAM PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 23-JUL-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAAS MRV PIE MEDICAL IMAGING B.V. 510(k) NO: K041682(TRADITIONAL) ATTN: CARLA DE VRIES PHONE NO : 31 43 3281322 BECANUSSTRAAT 13 D SE DECISION MADE: 27-JUL-04 MAASTRICHT, NETHERLANDS 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K041167(TRADITIONAL) ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 23-JUL-04 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIX CERVICAL PLATE PISHARODI SURGICALS, INC. 510(k) NO: K033951(TRADITIONAL) ATTN: J. D WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 01-JUL-04 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTS PANELS LDL CHOLESTEROL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K040693(TRADITIONAL) ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610 7736 ZIONSVILLE RD. SE DECISION MADE: 06-JUL-04 INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTS PANELS CHOL+GLU TEST PANEL POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K041750(SPECIAL) ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610 7736 ZIONSVILLE RD. SE DECISION MADE: 23-JUL-04 INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM POREX SURGICAL, INC. 510(k) NO: K040851(TRADITIONAL) ATTN: HOWARD MERCER PHONE NO : 678-479-1610 15 DART RD. SE DECISION MADE: 16-JUL-04 NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERA-CREAM, MODEL TCT004 PRIZM MEDICAL, INC. 510(k) NO: K032239(TRADITIONAL) ATTN: JULIE STEPHENS PHONE NO : 678-513-0693 111 LAUREL RIDGE DRIVE SE DECISION MADE: 30-JUL-04 ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO WALKER PL-200 POWER WHEELCHAIR PRO WALKER INC. 510(k) NO: K041336(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU, CHIUN ST. SE DECISION MADE: 20-JUL-04 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCI PROCTER & GAMBLE CO. 510(k) NO: K040999(TRADITIONAL) ATTN: MARK M ANDERSON PHONE NO : 513-634-5196 6110 CENTER HILL AVE. SE DECISION MADE: 09-JUL-04 CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMI PURNABINA SDN BHD 510(k) NO: K041004(TRADITIONAL) ATTN: LIEW YOON FONG PHONE NO : 607 787 9128 PLO 5, JALAN MAHSURI 1, 7.5KM SE DECISION MADE: 02-JUL-04 J. MERSING, KLUANG IND. AREA 510(k) STATEMENT KLUANG, JOHOR D. TAKZIM, MALAYSIA 86000 DEVICE: QUINTON Q-TE; RMS QUINTON CARDIOLOGY, INC. 510(k) NO: K041607(ABBREVIATED) ATTN: KAREN BROWNE PHONE NO : 425-402-2255 3303 MONTE VILLA PKWY. SE DECISION MADE: 16-JUL-04 BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORE NEEDLE BIOPSY REMINGTON MEDICAL, INC. 510(k) NO: K040266(TRADITIONAL) ATTN: MARIA P GRANITO PHONE NO : 800-989-0057 6830 MEADOWRIDGE CT. SE DECISION MADE: 09-JUL-04 ALPHARETTA, GA 30005 510(k) STATEMENT DEVICE: RESMED S8 PIONEER CPAP SYSTEM RESMED LTD. 510(k) NO: K041209(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2282 14040 DANIELSON ST. SE DECISION MADE: 01-JUL-04 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESMED HOSPITAL FULL FACE MASK RESMED LTD. 510(k) NO: K041362(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2400 14040 DANIELSON ST. SE DECISION MADE: 15-JUL-04 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOCD RESPIRONICS, INC. 510(k) NO: K041568(ABBREVIATED) ATTN: LOU ANNE KINNEY PHONE NO : 724-387-4292 1001 MURRY RIDGE LN. SE DECISION MADE: 21-JUL-04 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLAR PALATAL IMPLANT SYSTEM RESTORE MEDICAL INC. 510(k) NO: K040417(TRADITIONAL) ATTN: EDWARD W NUMAINVILLE PHONE NO : 651-634-3111 2800 PATTON RD. SE DECISION MADE: 28-JUL-04 ST PAUL, MN 55113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K031858(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 29-JUL-04 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K041321(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 09-JUL-04 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CS ROCHE DIAGNOSTICS CORP. 510(k) NO: K041812(SPECIAL) ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 27-JUL-04 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTX3320PSTN WIRELESS TELEHEALTH GATEWAY RTX HEALTHCARE A/S 510(k) NO: K041816(TRADITIONAL) ATTN: NIELS OLE ANDERSEN PHONE NO : 45 963 22300 STROEMMEN 6 SE DECISION MADE: 19-JUL-04 NOERRESUNDBY, DENMARK DK-9400 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SAS INFLUENZA B TEST SA SCIENTIFIC, INC. 510(k) NO: K041439(TRADITIONAL) ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 22-JUL-04 SAN ANTONIO, TX 78240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAS INFLUENZA A TEST SA SCIENTIFIC, INC. 510(k) NO: K041441(TRADITIONAL) ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 22-JUL-04 SAN ANTONIO, TX 78240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOTEK Q5 SAAT LTD. 510(k) NO: K041646(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 1468 HARWELL AVE. SE DECISION MADE: 22-JUL-04 CROFTON,, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MYSHELL SEDAT S.A. 510(k) NO: K040498(TRADITIONAL) ATTN: PETER C WOOD PHONE NO : 617-233-8788 4 HARVARD PLACE, # 1 SE DECISION MADE: 02-JUL-04 CHARLESTOWN, MA 02129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLIP-ON SPACER 20%; 40%; 50% SERONO, INC. 510(k) NO: K041084(TRADITIONAL) ATTN: PAMELA WILLIAMSON JOYCE PHONE NO : 781-681-2298 ONE TECHNOLOGY PLACE SE DECISION MADE: 15-JUL-04 ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES SHIMADZU CORP. 510(k) NO: K041763(TRADITIONAL) ATTN: TAKESHI OZAKI PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 13-JUL-04 TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAGNETOM C! MR SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K041111(TRADITIONAL) ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769 51 VALLEY STREAM PKWY. SE DECISION MADE: 16-JUL-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM ESPREE SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K041112(TRADITIONAL) ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769 51 VALLEY STREAM PKWY. SE DECISION MADE: 21-JUL-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNDECIDED SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K041484(TRADITIONAL) ATTN: RICHARD K ANDERSEN PHONE NO : 610-448-4362 51 VALLEY STREAM PKWY. SE DECISION MADE: 30-JUL-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KINETDX SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K041029(TRADITIONAL) ATTN: ANA LADINO PHONE NO : 610-448-1785 400 W. MORGAN ROAD SE DECISION MADE: 08-JUL-04 ANN ARBOR, MI 48108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEONARDO SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K040970(TRADITIONAL) ATTN: ANA LADINO PHONE NO : 610-448-1785 51 VALLEY STREAM PARKWAY SE DECISION MADE: 08-JUL-04 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINON SN-L402 LIGHTWEIGHT WHEELCHAIR SINON CORPORATION 510(k) NO: K041465(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 23-JUL-04 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVISION KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K041106(SPECIAL) ATTN: KIM KELLY PHONE NO : 901-399-6566 1450 E. BROOKS RD. SE DECISION MADE: 01-JUL-04 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR SMITH & NEPHEW, INC. 510(k) NO: K041328(TRADITIONAL) ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365 150 MINUTEMAN RD. SE DECISION MADE: 27-JUL-04 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMERAL STAPLE SMITH & NEPHEW, INC. 510(k) NO: K041355(TRADITIONAL) ATTN: JOHN REABE PHONE NO : 901-399-6670 1450 BROOKS RD. SE DECISION MADE: 30-JUL-04 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 721002 SMITH & NEPHEW, INC. 510(k) NO: K041453(TRADITIONAL) ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365 150 MINUTEMAN RD. SE DECISION MADE: 22-JUL-04 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX "ULTRAPERC" PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH S SMITHS MEDICAL 510(k) NO: K041348(TRADITIONAL) ATTN: BARRY SMITH PHONE NO : 440 130 3260551 MILITARY ROAD SE DECISION MADE: 13-JUL-04 HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE SMITHS MEDICAL ASD, INC. 510(k) NO: K041399(ABBREVIATED) ATTN: BRIAN D FARIAS PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 28-JUL-04 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONT SOFLEX CONTACT LENS INDUSTRIES LTD510(k) NO: K033655(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LN. SE DECISION MADE: 30-JUL-04 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: CRANEX BASEX D OR CRANEX EXCEL D SOREDEX INSTRUMENTARIUM CORP. 510(k) NO: K040382(TRADITIONAL) ATTN: KAI LANER PHONE NO : 358 103 94820 ELIMAENKATU 22 B SE DECISION MADE: 13-JUL-04 HELSINKI, FINLAND FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM SPINAL CONCEPTS, INC. 510(k) NO: K040096(TRADITIONAL) ATTN: LISA PETERSON PHONE NO : 512-533-1080 5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 01-JUL-04 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMESH 500E CEMENT RESTRICTOR SPINEOLOGY, INC. 510(k) NO: K033953(TRADITIONAL) ATTN: PAMELA SNYDER PHONE NO : 651-351-1011 1815 NORTHWESTERN AVE. SE DECISION MADE: 06-JUL-04 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER M SPIRE BIOMEDICAL INC 510(k) NO: K041559(TRADITIONAL) ATTN: DONALD FICKETT PHONE NO : 781-275-6001 ONE PATRIOTS PARK SE DECISION MADE: 30-JUL-04 BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-0 STEREOTAXIS, INC. 510(k) NO: K032937(TRADITIONAL) ATTN: PETER A TAKES PHONE NO : 314-615-6940 4041 FOREST PARK AVE. SE DECISION MADE: 01-JUL-04 ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOCKERTIR PURGE CONTROL (APC) SYSTEM STOCKERT INSTRUMENTE GMBH 510(k) NO: K041558(SPECIAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 02-JUL-04 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYTO-CHEX BCT STRECK LABORATORIES, INC. 510(k) NO: K040107(TRADITIONAL) ATTN: KERRIE OETTER PHONE NO : 402-537-5215 7002 SOUTH 109TH ST. SE DECISION MADE: 27-JUL-04 LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/181 SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K041174(TRADITIONAL) ATTN: MICHAEL LINSS PHONE NO : 497 614 7805-310 MUNZINGER STRASSE 7 SE DECISION MADE: 19-JUL-04 FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K041354(TRADITIONAL) ATTN: MICHAEL LINSS PHONE NO : 497 614 7805310 MUNZINGER STRASSE 7 SE DECISION MADE: 16-JUL-04 FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXCEM SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K041474(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 W. COLLINS AVE. SE DECISION MADE: 21-JUL-04 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) CHRONOS SYNTHES (USA) 510(k) NO: K041350(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 08-JUL-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORIAN SRS FAST SET PUTTY SYNTHES (USA) 510(k) NO: K041842(SPECIAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 23-JUL-04 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE TANITA CORP. OF AMERICA 510(k) NO: K040978(TRADITIONAL) ATTN: RHODA L VALERA PHONE NO : 847-434-3966 2625 CLEARBROOK DR. SE DECISION MADE: 22-JUL-04 ARLINGTON HGTS., IL 60005 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIA THE BINDING SITE 510(k) NO: K040466(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 16-JUL-04 2425 WEST OLYMPIC BLVD. 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: STRAUMANN TEMPORARY COPING THE STRAUMANN CO. 510(k) NO: K041070(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PL. 1601 TRAPELO RD. SE DECISION MADE: 23-JUL-04 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) TOTOKU ELECTRIC CO., LTD 510(k) NO: K041737(SPECIAL) ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA SE DECISION MADE: 13-JUL-04 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPT TREK DIAGNOSTIC SYSTEMS, LTD. 510(k) NO: K041534(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909 982 KEYNOTE CIRCLE SE DECISION MADE: 27-JUL-04 SUITE 6 510(k) STATEMENT CLEVELAND, OH 44131 DEVICE: TRIMED PLAN, VERSION 2.2 TRIMED SYSTEMS, INC 510(k) NO: K031088(TRADITIONAL) ATTN: SHERRY ZHANG PHONE NO : 636-227-0921 1804 LOEHR ESTATES CT. SE DECISION MADE: 23-JUL-04 BALLWIN, MO 63021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT TRINITY BIOTECH USA 510(k) NO: K033105(TRADITIONAL) ATTN: BONNIE DEJOY PHONE NO : 716-483-3851 2823 GIRTS RD. SE DECISION MADE: 13-JUL-04 JAMESTOWN, NY 14701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT TRINITY BIOTECH USA 510(k) NO: K033106(TRADITIONAL) ATTN: BONNIE B DEJOY PHONE NO : 716-483-3851 2823 GIRTS RD. SE DECISION MADE: 13-JUL-04 JAMESTOWN, NY 14701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE TYCO HEALTHCARE 510(k) NO: K040649(TRADITIONAL) ATTN: GAIL CHRISTIE PHONE NO : 508-261-8440 15 HAMPSHIRE ST. SE DECISION MADE: 15-JUL-04 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOVER ROB-NEL CATHETER TYCO HEALTHCARE 510(k) NO: K040897(TRADITIONAL) ATTN: WEI ZHAO PHONE NO : 508-261-8404 15 HAMPSHIRE ST. SE DECISION MADE: 20-JUL-04 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOVER RED RUBBER ROBINSON CATHETER TYCO HEALTHCARE 510(k) NO: K041243(TRADITIONAL) ATTN: WEI ZHAO PHONE NO : 508-261-8404 15 HAMPSHIRE ST. SE DECISION MADE: 07-JUL-04 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS UNILENS CORP., USA 510(k) NO: K041608(SPECIAL) ATTN: JOSEPHA BRUNO PHONE NO : 727-544-2531 10431 72ND ST. NORTH SE DECISION MADE: 07-JUL-04 LARGO, FL 33777 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJECTOR NEEDLE/SNARE UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K040961(TRADITIONAL) ATTN: GRETCHEN Y COHEN PHONE NO : 440-639-4494 5976 HEISELY RD. SE DECISION MADE: 08-JUL-04 MENTOR, OH 44060 510(k) STATEMENT DEVICE: COOK SIDEARM CORE TISSUE BIOPSY DEVICE UROLOGICAL INC. 510(k) NO: K041544(TRADITIONAL) ATTN: CINDY RUMPLE PHONE NO : 812-829-4891 1100 W. MORGAN STREET SE DECISION MADE: 22-JUL-04 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE USA INSTRUMENTS, INC. 510(k) NO: K041695(SPECIAL) ATTN: JAMES WRENN PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 23-JUL-04 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECLIPSE WITH AAA VARIAN MEDICAL SYSTEMS 510(k) NO: K041403(SPECIAL) ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 26-JUL-04 M/S H055 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94304-1129 DEVICE: FAST START TENS, MODEL FS 3001 VISION QUEST INDUSTRIES, INC. 510(k) NO: K041092(TRADITIONAL) ATTN: JAIME X PULLEY PHONE NO : 949-794-3865 18011 MITCHELL SO. SE DECISION MADE: 01-JUL-04 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K041473(TRADITIONAL) ATTN: JAMES LEE PHONE NO : 916-648-8460 1804 TRIBUTE RD., SUITE F SE DECISION MADE: 15-JUL-04 SACRAMENTO, CA 95815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIABIL BILIARY ENDOPROSTHESIS W. L. GORE & ASSOCIATES, INC. 510(k) NO: K041423(SPECIAL) ATTN: MICHAEL IVEY PHONE NO : 928-864-3790 3450 WEST KILTIE LN. SE DECISION MADE: 21-JUL-04 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUATRO M FEMORAL COMPONENT WHITESIDE BIOMECHANICS, INC. 510(k) NO: K033313(TRADITIONAL) ATTN: AMY CRANMER PHONE NO : 314-996-8540 12634 OLIVE BLVD. SE DECISION MADE: 28-JUL-04 ST. LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZILVER BILIARY STENT SYSTEM USW WILSON-COOK MEDICAL, INC. 510(k) NO: K040930(SPECIAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. & SE DECISION MADE: 02-JUL-04 5951 GRASSY CREEK BLVD. 510(k) SUMMARY AVAILABLE FROM FDA WINSTON-SALEM, NC 27105 DEVICE: RADIAL NAIL SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K040938(TRADITIONAL) ATTN: EHAB ESMAIL PHONE NO : 901-867-4732 5677 AIRLINE RD. SE DECISION MADE: 01-JUL-04 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K040980(TRADITIONAL) ATTN: ROGER D BROWN PHONE NO : 901-867-4457 5677 AIRLINE RD. SE DECISION MADE: 14-JUL-04 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR S HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K041586(SPECIAL) ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522 5677 AIRLINE RD. SE DECISION MADE: 09-JUL-04 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTERIOR COMPACT SYSTEM X-SPINE SYSTEMS 510(k) NO: K041469(TRADITIONAL) ATTN: JANET M WEBB PHONE NO : 312-643-1306 121 W. CHESTNUT ST. SE DECISION MADE: 30-JUL-04 # 3506 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60610 DEVICE: ZIMMER ANATOMIC II HIP PROSTHESIS ZIMMER, INC. 510(k) NO: K041109(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907 P.O. BOX 708 SE DECISION MADE: 20-JUL-04 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 284 TOTAL WITH SUMMARIES 246 TOTAL WITH STATEMENTS 38
Updated August 9, 2004
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