FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
510(k)s Final Decisions Rendered for August 2004 |
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
Updated September 7, 2004
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH