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Medical Devices
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August 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-AUG-2004 THROUGH 31-AUG-2004
DEVICE: ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CON
ABBOTT LABORATORIES 510(k) NO: K041687(ABBREVIATED)
ATTN: KENT SMITH PHONE NO : 847-938-4807
100 ABBOTT PARK RD. SE DECISION MADE: 18-AUG-04
ABBOTT PARK, IL 60064-3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
ACON LABORATORIES, INC. 510(k) NO: K041685(TRADITIONAL)
ATTN: EDWARD TUNG, PH.D. PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 30-AUG-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
ACON LABORATORIES, INC. 510(k) NO: K041946(TRADITIONAL)
ATTN: EDWARD TUNG, PH.D. PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 16-AUG-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACRO-MICRO DEPTH ELECTRODE
AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K041604(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 16-AUG-04
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-DRIP INFUSION CATHETER
ADVANCED INFUSION, INC. 510(k) NO: K042246(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 480-768-9747
6200 SOUTH MCCLINTOCK #6 SE DECISION MADE: 31-AUG-04
TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SILVER FOAM WOUND DRESSING
ADVANCED MEDICAL SOLUTIONS LTD. 510(k) NO: K032742(TRADITIONAL)
ATTN: JOHN GREEN PHONE NO : 440 160 6863500
ROAD THREE, SE DECISION MADE: 16-AUG-04
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: ANTIMICROBIAL ALGINATE DRESSING
ADVANCED MEDICAL SOLUTIONS LTD. 510(k) NO: K041316(TRADITIONAL)
ATTN: JOHN E GREENHAM PHONE NO : 440 160 6863500
ROAD THREE SE DECISION MADE: 05-AUG-04
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: BICONTACT HIP STEM AND FEMORAL HEAD
AESCULAP 510(k) NO: K040191(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 25-AUG-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EV APAN DIGITAL, MODEL K1VSM2000
AFP IMAGING CORP. 510(k) NO: K041120(TRADITIONAL)
ATTN: JAMES JOHNSON PHONE NO : 914-592-6100
250 CLEARBROOK RD. SE DECISION MADE: 30-AUG-04
ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCLAIM
AIR TECHNIQUES, INC. 510(k) NO: K042266(SPECIAL)
ATTN: JOSEPH CAREY PHONE NO : 516-214-5541
70 CANTIAGUE ROCK RD. SE DECISION MADE: 31-AUG-04
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: AUTOFUSER AMBULATORY INFUSION PUMP
ALGOS, LC 510(k) NO: K041585(TRADITIONAL)
ATTN: ROBERT J BARD PHONE NO : 949-235-0545
150 LAKE VILLAGE DRIVE SE DECISION MADE: 26-AUG-04
SUITE 203 510(k) SUMMARY AVAILABLE FROM FDA
ANN ARBOR, MI 48103
DEVICE: TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND F
AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K040819(TRADITIONAL)
ATTN: GREGORY FALK PHONE NO : 410-787-1300
7485 SHIPLEY AVE. SE DECISION MADE: 16-AUG-04
HANOVER, MD 21076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K041948(SPECIAL)
ATTN: KRISTYN BENSON PHONE NO : 952-930-6072
10700 BREN RD., WEST SE DECISION MADE: 11-AUG-04
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLO-RITE
AMERIFLO CORP. 510(k) NO: K041057(TRADITIONAL)
ATTN: MATTHEW THIE PHONE NO : 317-571-9471
478 GRADLE DR. SE DECISION MADE: 12-AUG-04
CARMEL, IN 46032 510(k) STATEMENT
DEVICE: C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
ANALOGIC CORP. 510(k) NO: K041434(TRADITIONAL)
ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000
8 CENTENNIAL DR. SE DECISION MADE: 06-AUG-04
PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORE-SI BONE GRAFT SUBSTITUTE
APATECH LTD. 510(k) NO: K040082(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 04-AUG-04
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K041711(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 26-AUG-04
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROGUIDE ANALYSIS SYSTEM
APPLIED NEUROSCIENCE INC. 510(k) NO: K041263(TRADITIONAL)
ATTN: ROBERT W THATCHER PHONE NO : 727-392-7851
228 176TH TERRACE DRIVE SE DECISION MADE: 03-AUG-04
ST. PETERSBURG, FL 33708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEMOR 5.0 IMAGE DISPLAY PROGRAM
AREEDA ASSOC., LTD. 510(k) NO: K041782(TRADITIONAL)
ATTN: JOSEPH AREEDA PHONE NO : 323-653-5515
516 NORTH CURSON AVE. SE DECISION MADE: 16-AUG-04
LOS ANGELES, CA 90036-1814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICC
ARROW INTL., INC. 510(k) NO: K042126(SPECIAL)
ATTN: SUZANNE SCHORLE PHONE NO : 610-378-0131
2400 BERNVILLE ROAD SE DECISION MADE: 27-AUG-04
READING, PA 19612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FIBERWIRE WITH SILK
ARTHREX, INC. 510(k) NO: K041589(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 05-AUG-04
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA GUIDE WIRE CONFIANZA PRO
ASAHI INTECC CO., LTD. 510(k) NO: K041531(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET SE DECISION MADE: 03-AUG-04
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
NEWPORT BEACH, CA 92660
DEVICE: ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K041451(TRADITIONAL)
ATTN: PETER STRZEPA PHONE NO : 512-836-5001
8200 CAMERON RD., SUITE C-140 SE DECISION MADE: 25-AUG-04
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA TECH IMPLANTS - DENTAL SYSTEM
ASTRA TECH, INC. 510(k) NO: K041492(TRADITIONAL)
ATTN: BRUCE R MANNING PHONE NO : 508-393-3100
96 WEST MAIN ST. SE DECISION MADE: 09-AUG-04
P.O. BOX 809 510(k) SUMMARY AVAILABLE FROM FDA
NORTHBOROUGH, MA 01532
DEVICE: SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
AZARY TECHNOLOGIES LLC. 510(k) NO: K041901(ABBREVIATED)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVE. SE DECISION MADE: 31-AUG-04
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CA
AZOG, INC. 510(k) NO: K041748(ABBREVIATED)
ATTN: AZUBUIKE OGALA PHONE NO : 908-213-2900
1011 US HWY 22 SE DECISION MADE: 09-AUG-04
PHILLIPSBURG, NJ 08865 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA TPN CONTAINER
B. BRAUN MEDICAL, INC. 510(k) NO: K041415(TRADITIONAL)
ATTN: AMY SMITH PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 04-AUG-04
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B. BRAUN BICARBONATE DIALYSATE
B. BRAUN MEDICAL, INC. 510(k) NO: K041683(TRADITIONAL)
ATTN: JENNIFER A PUNG PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 27-AUG-04
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM
BARCO NV BARCOVIEW 510(k) NO: K041508(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 27-AUG-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: PHACO CHOP NEEDLES
BAUSCH & LOMB, INC. 510(k) NO: K041998(SPECIAL)
ATTN: DENNIS POZZO PHONE NO : 636-226-3183
3365 TREE CT. INDUSTRIAL BLVD. SE DECISION MADE: 16-AUG-04
ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSOL DIALYSIS SOLUTION
BAXTER HEALTHCARE CORP. 510(k) NO: K041428(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN RD., MPR-A2E SE DECISION MADE: 27-AUG-04
MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K041643(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 18-AUG-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRING
BECTON DICKINSON 510(k) NO: K042061(SPECIAL)
ATTN: PETER ZURLO PHONE NO : 201-847-6447
1 BECTON DR. SE DECISION MADE: 26-AUG-04
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NE
BECTON, DICKINSON & CO. 510(k) NO: K041384(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 03-AUG-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-12
BECTON, DICKINSON AND CO. 510(k) NO: K041572(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIRCLE SE DECISION MADE: 12-AUG-04
SPARKS, MD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-OSTETIC
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K041889(SPECIAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-1644
1933 DAVIS ST. SUITE 307 SE DECISION MADE: 19-AUG-04
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINAXNOW INFLUENZA A & B TEST
BINAX, INC. 510(k) NO: K041049(TRADITIONAL)
ATTN: PAM ANGELL PHONE NO : 207-772-3988
217 READ ST. SE DECISION MADE: 10-AUG-04
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
BIOMET MANUFACTURING, INC. 510(k) NO: K041089(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 31-AUG-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML,
BIOTOP TECHNOLOGY CO., LTD. 510(k) NO: K041970(SPECIAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
58 FU-CHIUN STREET SE DECISION MADE: 03-AUG-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATER
BLACKSTONE MEDICAL, INC. 510(k) NO: K041939(SPECIAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513
90 BROOKDALE DR. SE DECISION MADE: 17-AUG-04
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODY CLOCK STIMPLUS AND STIMPLUS PRO
BODY CLOCK HEALTH CARE LTD 510(k) NO: K041359(TRADITIONAL)
ATTN: RASHELLE PRESTON PHONE NO : 44 020 85329595
108 GEORGE LANE SE DECISION MADE: 20-AUG-04
SOUTH WOODFORD 510(k) SUMMARY AVAILABLE FROM FDA
LONDON, UNITED KINGDOM E18 1AD
DEVICE: DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
BOSTON SCIENTIFIC CORP. 510(k) NO: K041827(SPECIAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 06-AUG-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEV
BOSTON SCIENTIFIC EPI 510(k) NO: K032884(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 408-970-1803
2525 WALSH AVE. SE DECISION MADE: 06-AUG-04
SANTA CLARA, CA 95051-1316 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2 CM PERIPHERAL CUTTING BALOON
BOSTON SCIENTIFIC IVT 510(k) NO: K041993(SPECIAL)
ATTN: RENUKA KRISHNAN PHONE NO : 858-503-1815
3574 RUFFIN RD. SE DECISION MADE: 16-AUG-04
SAN DIEGO, CA 92123-3597 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION HIP 3.0
BRAINLAB AG 510(k) NO: K040368(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 23-AUG-04
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRGUARD VALVED INTRODUCER
C.R. BARD, INC. 510(k) NO: K042036(TRADITIONAL)
ATTN: GLENN NORTON PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 23-AUG-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PIESOMETER, MODEL MK-1
CANAMET CANADIAN NATL MEDICAL TECH510(k) NO: K041169(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 24-AUG-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART AED G3 PRO
CARDIAC SCIENCE, INC. 510(k) NO: K040637(TRADITIONAL)
ATTN: KENNETH OLSON PHONE NO : 952-939-2912
5474 FELTL RD. SE DECISION MADE: 06-AUG-04
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURASUL BIPOLAR
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K040947(TRADITIONAL)
ATTN: AUDREY SWEARINGEN PHONE NO : 512-432-9255
9900 SPECTRUM DR. SE DECISION MADE: 27-AUG-04
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TD
CLINIQA CORPORATION 510(k) NO: K041898(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 16-AUG-04
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: ENDOTINE FOREHEAD TRIPLE DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K042078(SPECIAL)
ATTN: LORI DONDIEGO PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 27-AUG-04
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCI RETRIEVER, MODELS 90065, 90066
CONCENTRIC MEDICAL, INC. 510(k) NO: K033736(TRADITIONAL)
ATTN: KEVIN F MACDONALD PHONE NO : 650-938-2100
1380 SHOREBIRD WAY SE DECISION MADE: 11-AUG-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
CONCENTRIC MEDICAL, INC. 510(k) NO: K040745(TRADITIONAL)
ATTN: KEVIN F MACDONALD PHONE NO : 650-938-2100
1380 SHOREBIRD WAY SE DECISION MADE: 11-AUG-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
CONMED CORP. 510(k) NO: K041953(SPECIAL)
ATTN: IRA DUESLER PHONE NO : 315-624-3072
525 FRENCH RD. SE DECISION MADE: 09-AUG-04
UTICA, NY 13502 510(k) STATEMENT
DEVICE: PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, M
CONMED CORPORATION 510(k) NO: K032831(TRADITIONAL)
ATTN: IRA DUESLER PHONE NO : 315-624-3072
525 FRENCH ROAD SE DECISION MADE: 31-AUG-04
UTICA, NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COA
COOK, INC. 510(k) NO: K033843(TRADITIONAL)
ATTN: JENNIFER BOSLEY, MBA PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 12-AUG-04
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORPORATION 510(k) NO: K041796(SPECIAL)
ATTN: ELENA S JUGO PHONE NO : 786-313-2531
14201 N.W. 60TH AVENUE SE DECISION MADE: 03-AUG-04
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYURETHANE BLOOD PRESSURE CUFFS
D. E. HOKANSON, INC. 510(k) NO: K041689(SPECIAL)
ATTN: D. EUGENE HOKANSON PHONE NO : 425-882-1689
12840 N.E. 21ST PL. SE DECISION MADE: 06-AUG-04
BELLEVUE, WA 98005-1910 510(k) STATEMENT
DEVICE: HOVERJACK AIR PATIENT LIFT DEVICE
D.T. DAVIS ENTERPRISES LTD. 510(k) NO: K041503(TRADITIONAL)
ATTN: DAVID T DAVIS PHONE NO : 610-694-9600
513 S. CLEWELL ST. SE DECISION MADE: 12-AUG-04
BETHLEHEM, PA 18015-4537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
D.Y. INSTRUMENT, INC. 510(k) NO: K040580(TRADITIONAL)
ATTN: ANNA D LEE PHONE NO : 609-707-0743
30 MANNING LANE SE DECISION MADE: 26-AUG-04
CHERRY HILL, NJ 08003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED D-DIMER ASSAY
DADE BEHRING, INC. 510(k) NO: K041438(TRADITIONAL)
ATTN: KATHLEEN DRAYLYONS PHONE NO : 781-826-4551
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 11-AUG-04
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: N LATEX CYSTATIN
DADE BEHRING, INC. 510(k) NO: K041878(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 16-AUG-04
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
DANMETER A/S 510(k) NO: K032954(ABBREVIATED)
ATTN: HANNE NIELSEN PHONE NO : 45 63 112930
KILDEMOSEVEJ 13 SE DECISION MADE: 09-AUG-04
ODENSE C, DENMARK DK-5000 510(k) STATEMENT
DEVICE: GE DATEX-OHMEDA AISYS CARESTATION
DATEX-OHMEDA, INC. 510(k) NO: K042154(SPECIAL)
ATTN: DAN KOSEDNAR, RAC PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 31-AUG-04
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
DATRIX, INC. DBA OF JON BARRON, IN510(k) NO: K042022(TRADITIONAL)
ATTN: LAURA M LUHMANN PHONE NO : 760-480-8874
340 STATE PLACE SE DECISION MADE: 12-AUG-04
ESCONDIDO, CA 92029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MARE DENTAL OPERATIVE UNIT
DENIMED ELECTRONICA S.H. 510(k) NO: K041458(TRADITIONAL)
ATTN: GEORGE ECHEVERRI PHONE NO : 305-640-9894
1460 NW 107 AVE. SE DECISION MADE: 24-AUG-04
SUITE G 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33172
DEVICE: ORTHODONTIC CERAMIC BRACKETS
DENTSPLY INTL. 510(k) NO: K042178(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 30-AUG-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K041806(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT AVE. SE DECISION MADE: 03-AUG-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM ANTERIOR SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K041205(TRADITIONAL)
ATTN: JENNIFER MOONEY PHONE NO : 508-828-3649
325 PARAMOUNT DR. SE DECISION MADE: 17-AUG-04
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-ACETA/SAL CONTROLS
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K041666(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 17-AUG-04
WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT
CHARLOTTETOWN, PRINCE EDWARD, CANADA C1E 2A6
DEVICE: URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
DIRUI INDUSTRIAL CO., LTD. 510(k) NO: K040703(TRADITIONAL)
ATTN: JOSEPH F LUDFORD PHONE NO : 301-417-0220
7560 LINDBERGH DRIVE SE DECISION MADE: 26-AUG-04
GAITHERSBURG, MD 20879 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPOSITE/COMPOMER REPAIR KIT
DMG USA, INC. 510(k) NO: K041960(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
414 SOUTH STATE ST. SE DECISION MADE: 30-AUG-04
DOVER, DE 19901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODE
DOLPHIN MEDICAL INC. 510(k) NO: K040380(SPECIAL)
ATTN: JON WERNER PHONE NO : 813-431-1444
14240 N. 42ND STREET SE DECISION MADE: 31-AUG-04
APT 205 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33613
DEVICE: DR SYSTEMS PACS, RELEASE 6.1
DR. SYSTEMS, INC. 510(k) NO: K041935(TRADITIONAL)
ATTN: KIMBERLY J MEADE PHONE NO : 858-625-3344
10140 MESA RIM RD. SE DECISION MADE: 16-AUG-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
DRAEGER MEDICAL, INC. 510(k) NO: K042086(TRADITIONAL)
ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 31-AUG-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMG - ESSENTIAL GAS MODULE, MODEL M1013A
DRAEGET MEDICAL AG & CO. KGAA 510(k) NO: K041956(SPECIAL)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 09-AUG-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMO-DOP
DWL ELEKTRONISCHE SYSTEME GMBH 510(k) NO: K041915(TRADITIONAL)
ATTN: GEROLD WIDENHORN PHONE NO : 49 773 1797690
LANGERACH 4 SE DECISION MADE: 04-AUG-04
SIPPLINGEN, GERMANY D-78354 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
EBI, L.P. 510(k) NO: K033918(TRADITIONAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 16-AUG-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYSUS INFUSION SYSTEM
EKOS CORP. 510(k) NO: K041629(TRADITIONAL)
ATTN: JOCELYN KERSTEN PHONE NO :
22030 20TH AVENUE S.E. SE DECISION MADE: 06-AUG-04
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: GEODESIC EEG SYSTEM SERIES 100
ELECTRICAL GEODESICS, INCORPORATED510(k) NO: K033399(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 775-851-3804
1630 DUTCH RAVINE COURT SE DECISION MADE: 04-AUG-04
RENO, NV 89521-5160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEKTA NEUROMAG
ELEKTA NEUROMAG OY 510(k) NO: K041264(TRADITIONAL)
ATTN: BIRGITTA FAGERSTROM PHONE NO : 358 975 62400
ELIMAENKATU 22 B, PO BX 68 SE DECISION MADE: 10-AUG-04
HELSINKI, FINLAND FIN-00511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALICOLL
ENCOLL CORP. 510(k) NO: K040314(TRADITIONAL)
ATTN: SUBRAMANIAN GUNASEKARAN PHONE NO : 510-795-8581
5686 GERANIUM CT. SE DECISION MADE: 12-AUG-04
NEWARK, CA 94560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAHA DIVINO
ENTIFIC MEDICAL SYSTEMS, INC. 510(k) NO: K042017(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 26-AUG-04
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)
ENTRACARE, LLC 510(k) NO: K041034(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 31-AUG-04
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENCIL POINT NEEDLE
EPIMED INTERNATIONAL, INC. 510(k) NO: K041843(TRADITIONAL)
ATTN: CHRIS LAKE PHONE NO : 518-725-0209
141 SAL LANDRIO DR. SE DECISION MADE: 24-AUG-04
CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
JOHNSTOWN, NY 12095
DEVICE: OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH V
EST INTERNATIONAL CORPORATION 510(k) NO: K040108(TRADITIONAL)
ATTN: ELIZABETH DENG PHONE NO : 909-465-9188
7668 BELPINE PLACE SE DECISION MADE: 17-AUG-04
RANCHO CUCAMONGA, CA 91730 510(k) STATEMENT
DEVICE: MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
EV3 INC 510(k) NO: K042204(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 23-AUG-04
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
EXCEL TECH. LTD. 510(k) NO: K040358(TRADITIONAL)
ATTN: CAMERON MAHON PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE RD. SE DECISION MADE: 06-AUG-04
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) STATEMENT
DEVICE: XLTEK TREX MODEL#10309
EXCEL TECH. LTD. 510(k) NO: K042150(SPECIAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 27-AUG-04
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) STATEMENT
DEVICE: HC604 CPAP HUMIDIFIER
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K041900(TRADITIONAL)
ATTN: JAMES THOMPSON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 31-AUG-04
EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT STAT TROPONIN-I IMMUNOASSAY
FISHER DIAGNOSTICS 510(k) NO: K041192(TRADITIONAL)
ATTN: JOSEFINA INFANTAS PHONE NO : 540-869-8158
8365 VALLEY PIKE, PO BX 307 SE DECISION MADE: 12-AUG-04
MIDDLETOWN, VA 22645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01
FORTIFIER INTERNATIONAL CO., LTD. 510(k) NO: K041400(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO.58, FU-CHIUN ST. SE DECISION MADE: 24-AUG-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNAP-OFF SCREWS
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K041456(TRADITIONAL)
ATTN: CHRISTINE QUENDEZ PHONE NO : 33 298 556895
ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 25-AUG-04
QUIMPER, FRANCE 29000 510(k) STATEMENT
DEVICE: ANKYLOS DENTAL IMPLANT SYSTEM
FRIADENT GMBH 510(k) NO: K041509(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 26-AUG-04
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K041990(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-602-3774
419 WEST AVE. SE DECISION MADE: 06-AUG-04
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K042023(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-602-3753
419 WEST AVE. SE DECISION MADE: 25-AUG-04
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K042177(SPECIAL)
ATTN: LISA M BAUMHARDT PHONE NO : 262-293-1699
8200 WEST TOWER AVE. SE DECISION MADE: 27-AUG-04
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVA 4100, INNOVA 3100
GE MEDICAL SYSTEMS, INC. 510(k) NO: K042053(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 26-AUG-04
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
GE OEC MEDICAL SYSTEMS, INC. 510(k) NO: K041931(TRADITIONAL)
ATTN: JEFF WAGNER PHONE NO : 800-874-7378
384 WRIGHT BROTHERS DR. SE DECISION MADE: 26-AUG-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
GE OEC MEDICAL SYSTEMS, INC. 510(k) NO: K041932(TRADITIONAL)
ATTN: JEFF WAGNER PHONE NO : 800-874-7378
384 WRIGHT BROTHERS DR. SE DECISION MADE: 18-AUG-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K041563(TRADITIONAL)
ATTN: ANTHONY G AMITRANO PHONE NO : 973-889-2566
1500 LITTLETON RD. SE DECISION MADE: 27-AUG-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE BLUE VINYL EXAM GLOVES
GLORMED INTL., INC. 510(k) NO: K041945(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 20-AUG-04
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION
GUIDANT CORP. 510(k) NO: K042218(TRADITIONAL)
ATTN: LARAINE PANGELINA PHONE NO : 480-845-2250
3200 LAKESIDE DR. SE DECISION MADE: 31-AUG-04
SANTA CLARA, CA 95054-2807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINISHING WIRE SUPPORTRAK
GUIDANT CORPORATION 510(k) NO: K041762(TRADITIONAL)
ATTN: JENNIFER TANG PHONE NO : 651-582-6746
4100 HAMLINE AVE NORTH SE DECISION MADE: 06-AUG-04
ST PAUL, MN 55112-5498 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VA
GUIDANT CORPORATION 510(k) NO: K041981(SPECIAL)
ATTN: M. LAURIE WONG PHONE NO : 408-845-2014
3200 LAKESIDE DR. SE DECISION MADE: 20-AUG-04
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CO
GYRUS ENT L.L.C. 510(k) NO: K040996(TRADITIONAL)
ATTN: ALICIA E FARAGE PHONE NO : 901-373-0208
2925 APPLING RD. SE DECISION MADE: 20-AUG-04
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
HAEMACURE CORP. 510(k) NO: K041504(TRADITIONAL)
ATTN: ELAINE WHITMORE PHONE NO : 941-350-2631
7113 RIVER CLUB BLVD. SE DECISION MADE: 06-AUG-04
BRADENTON, FL 34202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "HANSON SCAR ADE"
HANSON MEDICAL, INC. 510(k) NO: K040307(TRADITIONAL)
ATTN: ERIK HANSON PHONE NO : 360-297-1997
P.O. BOX 1296 SE DECISION MADE: 12-AUG-04
KINGSTON, WA 98346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
HEALTH & LIFE CO., LTD. 510(k) NO: K042265(TRADITIONAL)
ATTN: PAUL HUNG PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 31-AUG-04
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
HEALTH HERO NETWORK, INC. 510(k) NO: K042273(SPECIAL)
ATTN: GEOFFREY J CLAPP PHONE NO : 650-559-1042
2570 WEST EL CAMINO REAL SE DECISION MADE: 31-AUG-04
SUITE 111 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94040-1309
DEVICE: ULTRASOUND LOCALIZATION SYSTEM ULS 0142
HMT HIGH MEDICAL TECHNOLOGIES AG 510(k) NO: K040741(TRADITIONAL)
ATTN: TRISH LANDRY PHONE NO : 202-546-1262
719 A STREET, NE SE DECISION MADE: 19-AUG-04
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC REFERENCE DATABASE
HOLOGIC, INC. 510(k) NO: K041266(TRADITIONAL)
ATTN: ANA RANDALL PHONE NO : 781-999-7313
35 CROSBY DR. SE DECISION MADE: 11-AUG-04
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURVIEW DX SOFTCOPY WORKSTATION
HOLOGIC, INC. 510(k) NO: K041555(TRADITIONAL)
ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203-731-8337
35 CROSBY DR. SE DECISION MADE: 09-AUG-04
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
HOME DIAGNOSTICS, INC. 510(k) NO: K042080(SPECIAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 19-AUG-04
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM
HOMMED LLC. 510(k) NO: K040651(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DR. SE DECISION MADE: 10-AUG-04
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
HOMMED LLC. 510(k) NO: K040799(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DR. SE DECISION MADE: 18-AUG-04
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM
HOSPIRA, INC. 510(k) NO: K042081(TRADITIONAL)
ATTN: TOM KOZMA PHONE NO : 224-212-4803
275 N. FIELD DR., BLDG. 2 SE DECISION MADE: 24-AUG-04
LAKE FOREST, IL 60045-5045 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO RESTORATION MODULAR SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K040734(TRADITIONAL)
ATTN: GINNY STAMBERGER PHONE NO : 201-831-5467
325 CORPORATE DRIVE SE DECISION MADE: 25-AUG-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSAWAVE DENTAL ER:YAG LASER SYSTEM
HOYA CONBIO 510(k) NO: K041710(TRADITIONAL)
ATTN: JIM GREEN PHONE NO : 800-532-1064
47733 FREMONT BLVD. SE DECISION MADE: 03-AUG-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LVI AESTHETIC LASER
HOYA PHOTONICS, INC. 510(k) NO: K041721(TRADITIONAL)
ATTN: JIM GREEN PHONE NO : 800-532-1064
47733 FREMONT BLVD. SE DECISION MADE: 05-AUG-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HES ULTRASONIC THERAPY APPLIANCE
HWANG SUN ENTERPRISE CO., LTD. 510(k) NO: K040798(TRADITIONAL)
ATTN: RICHARD C LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 04-AUG-04
SOUND BEACH, NY 11789 510(k) STATEMENT
DEVICE: TEGO NEEDLE FREE ACCESS ACCESS DEVICE
ICU MEDICAL, INC. 510(k) NO: K040710(TRADITIONAL)
ATTN: DALE FAIRCHILD PHONE NO : 949-366-2183
951 CALLE AMANECER SE DECISION MADE: 11-AUG-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
IMMUNOSTICS, INC. 510(k) NO: K041728(TRADITIONAL)
ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770
3505 SUNSET AVE. SE DECISION MADE: 11-AUG-04
OCEAN, NJ 07712 510(k) STATEMENT
DEVICE: INION TRINION BIODEGRADABLE MENISCUS SCREW
INION LTD. 510(k) NO: K031714(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 16-AUG-04
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
INNOVATIVE IMAGING, INC. 510(k) NO: K041947(TRADITIONAL)
ATTN: CYNTHIA KENDALL PHONE NO : 800-765-7226
9940 BUSINESS PARK DR. SE DECISION MADE: 16-AUG-04
SUITE 155 510(k) SUMMARY AVAILABLE FROM FDA
SACRAMENTO, CA 95827
DEVICE: MICRO PRIME
INNOVX MEDICAL, INC. 510(k) NO: K041650(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 16-AUG-04
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE
INOMED GMBH 510(k) NO: K041409(TRADITIONAL)
ATTN: ANDERS SKOGLUND PHONE NO :
KUNGSTENSGATAN 18, PO BX 7593 SE DECISION MADE: 20-AUG-04
SE-103 93 STOCKHOLM, SWEDEN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPANDABLE PEEK VBR IMPLANT
INTERPORE CROSS INTL. 510(k) NO: K040928(TRADITIONAL)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 27-AUG-04
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSS
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K041973(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 16-AUG-04
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: CRYOTIP
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K041562(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 09-AUG-04
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSATURA DENTAL
ISOTIS NV 510(k) NO: K031813(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 20-AUG-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHT GOLD XH
IVOCLAR VIVADENT, INC. 510(k) NO: K041433(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 800-533-6825
175 PINEVIEW DR. SE DECISION MADE: 19-AUG-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JMS BLOOD TUBING SETS
JMS NORTH AMERICA CORP. 510(k) NO: K032975(TRADITIONAL)
ATTN: SWEE CHEAU PHONE NO : 510-888-9093
22320 FOOTHILL BLVD., SE DECISION MADE: 16-AUG-04
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
HAYWARD, CA 94541
DEVICE: STORZ MODULITH, MODEL SLX-F2
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K040476(TRADITIONAL)
ATTN: RENATE A MACLAREN PHONE NO : 310-410-2731
600 CORPORATE POINTE SE DECISION MADE: 26-AUG-04
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARMA SCOOTER, MODEL KS-747.2
KARMA MEDICAL PRODUCTS CO., LTD. 510(k) NO: K041677(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 05-AUG-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG0147
KERBEROS PROXIMAL SOLUTIONS, INC. 510(k) NO: K041123(TRADITIONAL)
ATTN: TOM MASON PHONE NO : 650-254-1005
1400 TERRA BELLA AVE, SUITE K SE DECISION MADE: 26-AUG-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALCOMATE, MODEL CA2000
KHN SOLUTIONS, LLC 510(k) NO: K041334(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 11-AUG-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KMI DISTAL VOLAR RADIUS PLATE SYSTEM
KINETIKOS MEDICAL, INC. 510(k) NO: K041461(TRADITIONAL)
ATTN: JOHN G SPAMPINATO PHONE NO : 760-448-1706
6005 HIDDEN VALLEY RD, STE 180 SE DECISION MADE: 16-AUG-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLSA MARTIN HAND DISTRACTOR
KLS-MARTIN L.P. 510(k) NO: K042066(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
1239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 25-AUG-04
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: BIO 60
KODENT, INC. 510(k) NO: K041378(TRADITIONAL)
ATTN: DAE KYU CHANG PHONE NO : 714-537-0600
9778 KATELLA AVE. STE 215 SE DECISION MADE: 02-AUG-04
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURALITE-GL
LASER SCIENTIFIC 510(k) NO: K041262(TRADITIONAL)
ATTN: JOHN CROWNOVER PHONE NO : 512-733-8709
115 SUNDANCE PKWY #230B SE DECISION MADE: 13-AUG-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFECLINIC, MODEL 2400
LIFECLINIC INTERNATIONAL, INC. 510(k) NO: K040562(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 31-AUG-04
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
LINDE MEDICAL SENSORS AG 510(k) NO: K032291(TRADITIONAL)
ATTN: JEAN-PIERRE PALMA PHONE NO : 011 41 612788207
AUSTRASSE 25 SE DECISION MADE: 24-AUG-04
BASEL, SWITZERLAND CH-4051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARPAC MESSENGER MODEL #501
MARPAC, INC. 510(k) NO: K041485(TRADITIONAL)
ATTN: EVELYN TRUJILLO PHONE NO : 505-344-4740
8436 WASHINGTON PL. N.E. SE DECISION MADE: 02-AUG-04
ALBUQUERQUE, NM 87113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T
MAXI-AIDS, INC. 510(k) NO: K041778(ABBREVIATED)
ATTN: ELLIOT ZARETSKY PHONE NO :
42 EXECUTIVE BLVD. SE DECISION MADE: 31-AUG-04
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYOHEALTH CLENCHING INHIBITOR
MCI-MYOHEALTH SYSTEMS 510(k) NO: K040315(TRADITIONAL)
ATTN: DAVID BALDING PHONE NO : 949-412-0619
26552 TAMPICO PLACE SE DECISION MADE: 27-AUG-04
MISSION VIEJO, CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
MED2000 SPA 510(k) NO: K041974(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., STE 200 SE DECISION MADE: 24-AUG-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER C
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K041194(TRADITIONAL)
ATTN: MARY THORSNESS PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 16-AUG-04
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
MEDICAL ENERGY, INC. 510(k) NO: K041419(TRADITIONAL)
ATTN: DAVID P LEWING PHONE NO : 850-469-1727
225 EAST ZARAGOZA ST. SE DECISION MADE: 26-AUG-04
PENSACOLA, FL 32501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEW BRID
MEDICAL IMAGING SOLUTIONS, INC. 510(k) NO: K041780(TRADITIONAL)
ATTN: NANCY BUTCHER PHONE NO :
800 CENTRAL AVE. SE DECISION MADE: 11-AUG-04
JEFFERSON, LA 70121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
MEDICALCV, INC. 510(k) NO: K033685(TRADITIONAL)
ATTN: DENNY STEGER PHONE NO : 651-452-3000
9725 SOUTH ROBERT TRAIL SE DECISION MADE: 03-AUG-04
INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AARHUS ANCHORAGE SYSTEM
MEDICON, E.G. 510(k) NO: K041527(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 19-AUG-04
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSI S-500L RF GENERATOR
MEDSPHERE INTERNATIONAL, INC 510(k) NO: K041980(SPECIAL)
ATTN: ERIC KAO PHONE NO : 510-656-8232
48511 WARM SPRINGS BLVD. SE DECISION MADE: 06-AUG-04
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
FREMONT, CA 94539
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K041197(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 09-AUG-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K042025(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 25-AUG-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPS CURVED BUR
MEDTRONIC XOMED, INC. 510(k) NO: K041985(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-434-7487
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 12-AUG-04
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POLYGRAM NET BIOFEEDBACK APPLICATION
MEDTRONIC, INC. 510(k) NO: K041244(TRADITIONAL)
ATTN: JULIE GOODE PHONE NO : 763-514-9670
4000 LEXINGTON AVE., NORTH SE DECISION MADE: 12-AUG-04
SHOREVIEW, MN 55126-2893 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM
MEDX, INC. 510(k) NO: K041840(TRADITIONAL)
ATTN: FLOYD R ROWAN PHONE NO : 800-323-6339
3456 NORTH RIDGE AVE., #100 SE DECISION MADE: 20-AUG-04
ARLINGTON HEIGHTS, IL 60004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCARD TOXINS A & B, MODEL 712050
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K041003(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 20-AUG-04
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCARD STAT! RSV MODEL #750630
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K041445(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 13-AUG-04
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABRESOURCE DRAPE
MINRAD, INC. 510(k) NO: K041846(TRADITIONAL)
ATTN: JOHN MCNEIRNEY PHONE NO : 716-855-1068
847 MAIN ST. SE DECISION MADE: 26-AUG-04
BUFFALO, NY 14203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
MRI DEVICES CORPORATION 510(k) NO: K042103(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DRIVE SE DECISION MADE: 16-AUG-04
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
NANMA MFG CO., LTD. 510(k) NO: K041573(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 25-AUG-04
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: MODIFICATION TO NC-STAT
NEUROMETRIX, INC. 510(k) NO: K041320(TRADITIONAL)
ATTN: JOSEPH F BURKE PHONE NO : 781-314-2706
62 FOURTH AVE. SE DECISION MADE: 12-AUG-04
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXFLEX TOTAL HIP SYSTEM
NEXMED, INC. 510(k) NO: K033580(SPECIAL)
ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO SE DECISION MADE: 05-AUG-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
NEXUS MEDICAL, LLC 510(k) NO: K041845(TRADITIONAL)
ATTN: AL BOEDEKER PHONE NO : 913-451-2234
11315 STRANG LINE ROAD SE DECISION MADE: 24-AUG-04
LENEXA, KS 66215 510(k) STATEMENT
DEVICE: NOBEL BIOCARE ENDOSSEOUS IMPLANTS
NOBEL BIOCARE USA, INC. 510(k) NO: K041661(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO :
22715 SAVI RANCH PKWY. SE DECISION MADE: 26-AUG-04
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELDIRECT OD IMPLANT
NOBEL BIOCARE USA, INC. 510(k) NO: K041876(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 20-AUG-04
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERSEAL
NOBLE FIBER TECHNOLOGIES 510(k) NO: K033587(TRADITIONAL)
ATTN: PATRICIA DAVIDSON PHONE NO : 877-978-2842
421 S. STATE ST. SE DECISION MADE: 05-AUG-04
CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
NOVABONE PRODUCTS, LLC 510(k) NO: K041613(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 25-AUG-04
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
NOVAMIN TECHNOLOGY, INC. 510(k) NO: K041371(TRADITIONAL)
ATTN: DAVID C GREENSPAN PHONE NO : 386-418-1551
13709 PROGRESS BLVD, # 23 SE DECISION MADE: 23-AUG-04
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMP F
NOVOCOL, INC. 510(k) NO: K040343(TRADITIONAL)
ATTN: STEVE RUDOLPH PHONE NO : 303-665-7535
416 SOUTH TAYLOR AVE. SE DECISION MADE: 03-AUG-04
LOUISVILLE, CO 80027 510(k) STATEMENT
DEVICE: MICROSELECTRON PDR
NUCLETRON CORP. 510(k) NO: K041933(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-872-4435
8671 ROBERT FULTON DRIVE SE DECISION MADE: 18-AUG-04
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUNC IVF MULTIDISH 4 WELLS NUNCLON
NUNC A/S 510(k) NO: K040717(TRADITIONAL)
ATTN: HENRIK KVISTGAARD PHONE NO : 454 631 2154
KAMSTRUPUEJ 90, KAMSTRUP SE DECISION MADE: 12-AUG-04
ROSKILDE, DENMARK DK-4000 510(k) STATEMENT
DEVICE: NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
NUVASIVE, INC. 510(k) NO: K041447(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-527-1918
10065 OLD GROVE RD. SE DECISION MADE: 16-AUG-04
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE PUREFLOW-B SOLUTION
NXSTAGE MEDICAL, INC. 510(k) NO: K042045(SPECIAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4746
439 SOUTH UNION ST.,STE 501 SE DECISION MADE: 27-AUG-04
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
OLYMPUS AMERICA INC. 510(k) NO: K041668(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-556-9697
3131 W. ROYAL LANE SE DECISION MADE: 19-AUG-04
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS BF TYPE UC160-OL8
OLYMPUS CORPORATION 510(k) NO: K042140(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 18-AUG-04
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OLYMPUS STERILIZATION TRAYS
OLYMPUS WINTER & IBE GMBH 510(k) NO: K033222(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DR. SE DECISION MADE: 02-AUG-04
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CA
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K041720(TRADITIONAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 25-AUG-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUC
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K041799(TRADITIONAL)
ATTN: CAREY MAYO PHONE NO : 585-453-3482
100 INDIGO CREEK DR. SE DECISION MADE: 25-AUG-04
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
ORTHOS (UK) LIMITED 510(k) NO: K041616(TRADITIONAL)
ATTN: ALAN RORKE PHONE NO : 442 753 76377
THE STABLES, LEIGH COURT SE DECISION MADE: 25-AUG-04
ABBOTS LEIGH 510(k) SUMMARY AVAILABLE FROM FDA
BRISTOL NORTH SOMERSET, UNITED KINGDOM BS8 3RA
DEVICE: PERMANENT PACING LEAD, MODEL PY2
OSCOR INC. 510(k) NO: K041809(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 06-AUG-04
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600
OSTEOBIOLOGICS, INC. 510(k) NO: K033707(SPECIAL)
ATTN: GABRIELE G NIEDERAUER, PH.D.PHONE NO : 210-690-2131
UNIVERSITY BUSINESS PARK SE DECISION MADE: 16-AUG-04
12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249-3308
DEVICE: WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
PANBIO LIMITED 510(k) NO: K041231(TRADITIONAL)
ATTN: CRAIG BREADMORE PHONE NO : 617 335 71177
116 LUTWYCHE RD. SE DECISION MADE: 10-AUG-04
WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K041776(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 03-AUG-04
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASSIER-DUVAL TELSCOPIC IM SYSTEM
PEGA MEDICAL INC. 510(k) NO: K041393(TRADITIONAL)
ATTN: ARIEL R DUJOVNE PHONE NO : 514 322 8560
9260 BOUL. VIAU SE DECISION MADE: 17-AUG-04
MONTREAL (QUEBEC), CANADA H1R 2V8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTA T
PENLON LTD. 510(k) NO: K041076(SPECIAL)
ATTN: ALAN GREEN PHONE NO : 44 123 5547000
BARTON LANE SE DECISION MADE: 09-AUG-04
ABINGDON, UNITED KINGDOM OX14 3PH 510(k) STATEMENT
DEVICE: PERFORMANCE WATER TREATMENT SYSTEM
PERFORMANCE WATER SYSTEMS, LLC 510(k) NO: K033648(TRADITIONAL)
ATTN: ROBERT DOWNEY PHONE NO : 708-396-0136
13601 SOUTH KENTON AVE. SE DECISION MADE: 09-AUG-04
CRESTWOOD, IL 60445 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO
PERMOBIL A.B. 510(k) NO: K041219(TRADITIONAL)
ATTN: JAN' ASTROM PHONE NO : 466 059 5959
BOX 120 SE DECISION MADE: 04-AUG-04
TIMRA, SWEDEN S-861 23 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASMAJET SYSTEM
PLASMA SURGICAL, LTD. 510(k) NO: K030819(TRADITIONAL)
ATTN: PETER F GIBSON PHONE NO : 441 264 711080
18, GROSVENOR STREET SE DECISION MADE: 05-AUG-04
LONDON, UNITED KINGDOM W1K 4QQ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIGHTFORM
PLASTIC SURGERY SOLUTIONS, LLC 510(k) NO: K041996(TRADITIONAL)
ATTN: PHIL CARTER PHONE NO : 954-648-6617
1150 N. 35TH AVE., STE. 490 SE DECISION MADE: 03-AUG-04
HOLLYWOOD, FL 33021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-3
PMT CORP. 510(k) NO: K033730(TRADITIONAL)
ATTN: ERIC CAILLE PHONE NO : 952-470-0866
1500 PARK RD. SE DECISION MADE: 03-AUG-04
CHANHASSEN, MN 55317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMEDCO OC LIGHT FOBT TEST
POLYMEDCO, INC. 510(k) NO: K041297(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 425-814-1514
510 FURNACE DOCK RD. SE DECISION MADE: 12-AUG-04
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
PROGENY, INC. 510(k) NO: K041831(TRADITIONAL)
ATTN: E.M. DOLAN PHONE NO : 847-850-3800
1407 BARCLAY BLVD. SE DECISION MADE: 09-AUG-04
BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TE
PROPPER MFG. CO., INC. 510(k) NO: K031152(TRADITIONAL)
ATTN: JOHN D DYCKMAN PHONE NO : 800-221-2280
36-04 SKILLMAN AVE. SE DECISION MADE: 17-AUG-04
LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G5 I HBA1C TEST, G5 II HBA1C TEST
PROVALIS DIAGNOSTICS LTD. 510(k) NO: K041635(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE RD. SE DECISION MADE: 16-AUG-04
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR
PROXIMA THERAPEUTICS, INC. 510(k) NO: K041929(SPECIAL)
ATTN: MARTINE D SCHNEIDER PHONE NO : 407-323-9388
2555 MARCONI DRIVE, SUITE 220 SE DECISION MADE: 26-AUG-04
ALPHARETTA, GA 30005-2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
PT. SMART GLOVE INDONESIA 510(k) NO: K040792(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 006 206 17944946
KAWASAN INDUSTRI MEDAN STAR J1 SE DECISION MADE: 12-AUG-04
RAYA MEDAN-LUBUK PAKAM KM.19 510(k) STATEMENT
TG MORAWA-DELI SERDANG UTARA, INDONESIA 20362
DEVICE: POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND W
PT. SMART GLOVE INDONESIA 510(k) NO: K041848(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 62 061 7942433
KAWASAN INDUSTRI MEDAN STAR JL SE DECISION MADE: 20-AUG-04
RAYA MEDAN-LUBUK PAKAM KM.19 510(k) STATEMENT
TG MORAWA-DELI SERDANG, INDONESIA 20362
DEVICE: RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K041997(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-565-1227
22 TERRY AVE. SE DECISION MADE: 27-AUG-04
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAVEN PROTEST - STEAM
RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K041386(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781
8607 PARK DR. SE DECISION MADE: 09-AUG-04
OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPOT CHECK PULSE OXIMETER,512/513
RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K032949(TRADITIONAL)
ATTN: MICHAEL J MALIS PHONE NO : 203-697-6442
5 TECHNOLOGY DR. SE DECISION MADE: 23-AUG-04
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIDAL WAVE SP MODEL 710/715
RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K032971(TRADITIONAL)
ATTN: MICHAEL J MALIS PHONE NO : 203-697-6442
5 TECHNOLOGY DR. SE DECISION MADE: 26-AUG-04
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 22
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K041610(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 19-AUG-04
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCOON HYGIENIST
SATELEC 510(k) NO: K040529(TRADITIONAL)
ATTN: JEAN-LUC BOULNOIS PHONE NO : 781-239-8108
70 WALNUT ST. SE DECISION MADE: 19-AUG-04
WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITORING SYSTEM, MODEL ARGUS PB-2200
SCHILLER AG 510(k) NO: K033738(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 414 176 64252
ALTGASSE 68 SE DECISION MADE: 24-AUG-04
BAAR, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARRIAZO PENDULAR
SCHWIND EYE-TECH-SOLUTIONS GMBH & 510(k) NO: K032910(TRADITIONAL)
ATTN: WILLIAM T KELLEY PHONE NO : 949-292-8477
23832 VIA MONTE SE DECISION MADE: 30-AUG-04
COTO DE CAZA, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVISO
SCIENTIFIC PHARMACEUTICALS, INC. 510(k) NO: K041886(TRADITIONAL)
ATTN: JAN A ORLOWSKI PHONE NO : 909-595-9922
3221 PRODUCER WAY SE DECISION MADE: 04-AUG-04
POMONA, CA 91768-3916 510(k) STATEMENT
DEVICE: CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
SEAL POLYMER INDUSTRIES BHD. 510(k) NO: K042101(TRADITIONAL)
ATTN: CHUN CHOOI FONG PHONE NO : 605 322 3200
LOT 72706,JALAN LAHAT, KAWASAN SE DECISION MADE: 27-AUG-04
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9
SEIN ELECTRONICS CO., LTD. 510(k) NO: K042014(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 06-AUG-04
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
SEIN ELECTRONICS CO., LTD. 510(k) NO: K042138(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 24-AUG-04
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENORX INTRODUCER
SENORX, INC. 510(k) NO: K042098(SPECIAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 19-AUG-04
ALISO VIEJO, CA 92656 510(k) STATEMENT
DEVICE: SENTEC DIGITAL MONITOR MODEL #SDM
SENTEC INC. 510(k) NO: K041548(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 09-AUG-04
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES
SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K041276(TRADITIONAL)
ATTN: WUNAN HUANG PHONE NO : 864-877-1944
150J WEST PHILLIPS ROAD SE DECISION MADE: 20-AUG-04
GREER, SC 29650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED VINYL EXAM GLOVES
SHIJIAZHUANG WALLY PLASTICS CO., L510(k) NO: K041379(TRADITIONAL)
ATTN: IRIS YANG PHONE NO : 886 7 7332168
NO 78 TONGDA RD. SE DECISION MADE: 31-AUG-04
JINZHOU CITY, HEBEI, CHINA 052260 510(k) STATEMENT
DEVICE: SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW1
SHINING WORLD HALTHCARE CO., LTD. 510(k) NO: K033027(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
6F, NO.8, LANE 7, WU-CHUN RD. SE DECISION MADE: 12-AUG-04
WU-KU INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 248
DEVICE: ACUSON CV70 CARDIOVASCULAR SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042044(SPECIAL)
ATTN: PATRICK LYNCH PHONE NO : 425-557-1825
1230 SHOREBIRD WAY SE DECISION MADE: 13-AUG-04
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: CYPRESS ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042055(SPECIAL)
ATTN: PATRICK LYNCH PHONE NO : 425-557-1825
1230 SHOREBIRD WAY SE DECISION MADE: 16-AUG-04
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
SIGMA INTL. 510(k) NO: K042121(TRADITIONAL)
ATTN: CHARLES L MARTINA PHONE NO : 585-798-3901
711 PARK AVE. SE DECISION MADE: 26-AUG-04
MEDINA, NY 14103-0756 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CURVED PEEK TETRIS SPINAL IMPLANT
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K041888(SPECIAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873
5050 OLSON MEMORIAL HWY SE DECISION MADE: 10-AUG-04
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
SMITH & NEPHEW, INC. 510(k) NO: K040542(TRADITIONAL)
ATTN: MARION W GORDON PHONE NO : 978-749-1371
150 MINUTEMAN RD. SE DECISION MADE: 19-AUG-04
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW GRAFT DELIVERY SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K041976(TRADITIONAL)
ATTN: KIM P KELLY PHONE NO : 901-399-6566
1450 E. BROOKS RD. SE DECISION MADE: 23-AUG-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRABIO
SONOTECH, INC. 510(k) NO: K033178(TRADITIONAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9121
774 MARINE DR. SE DECISION MADE: 04-AUG-04
BELLINGHAM, WA 98225 510(k) STATEMENT
DEVICE: SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETI
SONTRA MEDICAL INC. 510(k) NO: K040525(TRADITIONAL)
ATTN: ALBERT FARINHA PHONE NO : 508-553-8850
10 FORGE PARKWAY SE DECISION MADE: 17-AUG-04
FRANKLIN, MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMULEN COLLAGEN
SOUTHWEST TECHNOLOGIES, INC. 510(k) NO: K030774(TRADITIONAL)
ATTN: EDWARD I STOUT PHONE NO : 816-221-2442
1746 LEVEE RD. SE DECISION MADE: 09-AUG-04
KANSAS CITY, MO 64116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAME BONE VOID FILLER
STRYKER BIOTECH 510(k) NO: K041421(TRADITIONAL)
ATTN: SHARON MCDERMOTT PHONE NO : 508-416-5200
35 SOUTH ST. SE DECISION MADE: 26-AUG-04
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K033135(TRADITIONAL)
ATTN: MIKE HILLDOERFER PHONE NO : 408-754-2664
5900 OPTICAL CT. SE DECISION MADE: 09-AUG-04
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE VERTEBRAL SPACER
STRYKER SPINE 510(k) NO: K040731(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 05-AUG-04
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STURDY MANUAL RESUSCITATOR
STURDY INDUSTRIAL CO., LTD 510(k) NO: K032596(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 214-632-0636
6833 SAINT LAWRENCE STREET SE DECISION MADE: 05-AUG-04
PLANO, TX 75024 510(k) STATEMENT
DEVICE: SURFIX KNEE OSTEOTOMY SYSTEM
SURFIX TECHNOLOGIES 510(k) NO: K041601(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 27-AUG-04
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K041173(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 497 614 7805310
MUNZINGER STRASSE 7 SE DECISION MADE: 02-AUG-04
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA GLIADIN IGG ANTIBODIES
SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K041357(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 497 614 7805310
MUNZINGER STRASSE 7 SE DECISION MADE: 02-AUG-04
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) TITANIUM WIRE
SYNTHES (USA) 510(k) NO: K041333(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 27-AUG-04
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
SYNTHES (USA) 510(k) NO: K041887(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 19-AUG-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K042005(SPECIAL)
ATTN: SHU-MEI WU PHONE NO : 886 2 66358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 27-AUG-04
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: TEH LIN POWERED WHEELCHAIR, MDG-601
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K041752(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 05-AUG-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMENTEK
TEKNIMED SA 510(k) NO: K041493(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 19-AUG-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
TERANG NUSA SDN BHD 510(k) NO: K041436(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 774 7171
1, JALAN 8, SE DECISION MADE: 20-AUG-04
PENGKALAN CHEPA 2 IND. ZONE 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: TERUMO CIRCUIT CONNECTORS
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K041697(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 11-AUG-04
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REA
THERMO ELECTRON CORPORATION 510(k) NO: K041657(TRADITIONAL)
ATTN: BOLA NICHOLSON PHONE NO : 303-581-6425
331 SOUTH 104TH STREET SE DECISION MADE: 30-AUG-04
LOUISVILLE, CO 80027 510(k) STATEMENT
DEVICE: AEQUALIS REVERSED SHOULDER PROSTHESIS
TORNIER S.A. 510(k) NO: K041873(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 33 4 76613898
ZIRST-161, RUE LAVOISIER SE DECISION MADE: 25-AUG-04
MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLAB MICROCAL SERUM CONTROLS
TROUBLE SHOOTER CONSULING, INC. 510(k) NO: K041871(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570 620 0198
VIA RINA MONTI N 26 C.A.P. SE DECISION MADE: 16-AUG-04
ROME, ITALY 00155 510(k) STATEMENT
DEVICE: PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING D
TUTTNAUER USA CO. LTD. 510(k) NO: K032192(ABBREVIATED)
ATTN: MARK M YACURA PHONE NO : 202-452-7949
1776 K STREET, N.W. SE DECISION MADE: 12-AUG-04
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-7910
DEVICE: MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG
URESIL, LLC 510(k) NO: K041995(SPECIAL)
ATTN: MATTHEW MAHON PHONE NO : 847-982-0200
5418 W. TOUHY AVE. SE DECISION MADE: 19-AUG-04
SKOKIE, IL 60077 510(k) STATEMENT
DEVICE: MARK III PHASED ARRAY SHOULDER COIL
USA INSTRUMENTS, INC. 510(k) NO: K042009(SPECIAL)
ATTN: JAMES WRENN PHONE NO : 330-995-8578
1515 DANNER DR. SE DECISION MADE: 11-AUG-04
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0T 8-CHANNEL CTL SPINE ARRAY
USA INSTRUMENTS, INC. 510(k) NO: K042186(SPECIAL)
ATTN: JAMES WRENN PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 26-AUG-04
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
USA INSTRUMENTS, INC. 510(k) NO: K042207(TRADITIONAL)
ATTN: JAMES WRENN PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 26-AUG-04
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
USFILTER 510(k) NO: K031502(TRADITIONAL)
ATTN: EDWARD L ARMSTRONG PHONE NO : 719-550-2207
725 WOOTEN RD. SE DECISION MADE: 27-AUG-04
COLORADO SPRINGS, CO 80915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPOTHERM MODEL#2000I, 200H
VAPOTHERM, INC. 510(k) NO: K042245(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W.WATERVIEW CT. SE DECISION MADE: 30-AUG-04
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ON-BOARD IMAGER DEVICE
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K041519(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 04-AUG-04
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFUSIONCATH, MODELS VI0020, VI20024, VI0028, VI0032, VI0036, VI
VEIN RX, LLC 510(k) NO: K041517(TRADITIONAL)
ATTN: SCOTT JAHRMARKT PHONE NO : 305-716-7000
8210 NW 27TH ST. SE DECISION MADE: 05-AUG-04
MIAMI, FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTURE WIRE CONTROL CATHETER
VELOCIMED INC. 510(k) NO: K040922(TRADITIONAL)
ATTN: SEW-WAH TAY PHONE NO : 763-463-4707
11400 73RD AVENUE NORTH SE DECISION MADE: 18-AUG-04
SUITE 134 510(k) SUMMARY AVAILABLE FROM FDA
MINEAPOLIS, MN 55369-5567
DEVICE: DENFIL
VERICOM CO., LTD. 510(k) NO: K042124(TRADITIONAL)
ATTN: MYUNG-HWAN OH PHONE NO : 82 31 4412881
#606,5TH DONGYOUNG VENTURESTEL SE DECISION MADE: 13-AUG-04
199-32, ANYANG 7-DONG,MANAN-GU 510(k) SUMMARY AVAILABLE FROM FDA
ANYANG-SI, GYEONGGI-DO, REPUBLIC OTHIRD PARTY REVIEW
DEVICE: VILEX BONE PLATE SYSTEM
VILEX, INC. 510(k) NO: K041287(TRADITIONAL)
ATTN: ABRAHAM LAVI PHONE NO : 412-655-7550
345 OLD CURRY HOLLOW RD. SE DECISION MADE: 05-AUG-04
PITTSBURGH, PA 15236 510(k) STATEMENT
DEVICE: TALUS OF VILEX (TOV)
VILEX, INC. 510(k) NO: K041289(TRADITIONAL)
ATTN: ABRAHAM LAVI PHONE NO : 412-655-7550
345 OLD CURRY HOLLOW RD. SE DECISION MADE: 05-AUG-04
PITTSBURGH, PA 15236 510(k) STATEMENT
DEVICE: EZ SMART
VIP INTERNATIONAL WHOLESALERS, COR510(k) NO: K040848(TRADITIONAL)
ATTN: DAVID L ROSEN PHONE NO : 202-238-7749
1625 MASSACHUSETTS AVE. SE DECISION MADE: 11-AUG-04
STE. 300 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
W.H.P.M., INC. 510(k) NO: K041202(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 12-AUG-04
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
WELCH ALLYN, INC. 510(k) NO: K040490(ABBREVIATED)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4133
4341 STATE ST. RD. SE DECISION MADE: 18-AUG-04
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
WEST PHARMACEUTICAL SERVICES, INC.510(k) NO: K041691(TRADITIONAL)
ATTN: DAVID WEISER PHONE NO : 610-594-2931
101 GORDON DR. SE DECISION MADE: 05-AUG-04
LIONVILLE, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOMATRIX PUTTY
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K041168(TRADITIONAL)
ATTN: ROGER D BROWN PHONE NO : 901-867-4457
5677 AIRLINE RD. SE DECISION MADE: 02-AUG-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
ZIBO BORUI PLASTIC & RUBBER PRODUC510(k) NO: K042028(TRADITIONAL)
ATTN: MARY ANN DOUCETTE PHONE NO : 760-318-4973
10 SETON COURT SE DECISION MADE: 09-AUG-04
RANCHO MIRAGE, CA 92270 510(k) STATEMENT
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 262
TOTAL WITH SUMMARIES 222
TOTAL WITH STATEMENTS 40
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