510(k)s Final Decisions Rendered for August 2004

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horizonal rule
510(k)s Final Decisions Rendered for August 2004

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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
horizonal rule
Center for Devices and Radiological Health / CDRH