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Medical Devices
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July 2004 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-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
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