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Medical Devices
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March 2007 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAR-2007 THROUGH 31-MAR-2007
DEVICE: AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
AALTO SCIENTIFIC LTD. 510(k) NO: K070223(TRADITIONAL)
ATTN: ALAN VEKICH PHONE NO : 760-431-7922
1959 KELLOGG AVE. SE DECISION MADE: 13-MAR-07
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELUXE NEBULIZER
ACCESS POINT MEDICAL, L.L.C. 510(k) NO: K063449(TRADITIONAL)
ATTN: JAMES W SANDBERG PHONE NO : 971-409-9186
835 NW PEBBLE BEACH WAY SE DECISION MADE: 01-MAR-07
BEAVERTON, OR 97006 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ZIRBLANK-PS AND ZIRBLANK-FS
ACUCERA, INC. 510(k) NO: K070045(TRADITIONAL)
ATTN: KYUNG-BIN LEE PHONE NO : 82 31 5276940
539 JINBUL-LI SE DECISION MADE: 26-MAR-07
JINJEOP, NAMYANGJU 510(k) SUMMARY AVAILABLE FROM FDA
GYEONGGI, REPUBLIC OF KOREA 472-861
DEVICE: ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
ADVANTAGE MEDICAL CABLES, INC. 510(k) NO: K063863(TRADITIONAL)
ATTN: KEN KENDRICKS PHONE NO : 954-345-9800
10630 WILES RD. SE DECISION MADE: 20-MAR-07
CORAL SPRINGS, FL 33076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S4 SPINAL SYSTEM
AESCULAP 510(k) NO: K062085(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 02-MAR-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO S4 SPINAL SYSTEM
AESCULAP, INC. 510(k) NO: K062327(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 14-MAR-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH III IOL DELIVERY SYSTEM
ALCON MANUFACTURING, LTD. 510(k) NO: K063155(TRADITIONAL)
ATTN: CATHERINE G GOBLE PHONE NO : 817-551-6816
6201 SOUTH FREEWAY SE DECISION MADE: 27-MAR-07
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED PHACOEMULSIFICATION TIPS
ALLIANCE MEDICAL CORP. 510(k) NO: K060648(TRADITIONAL)
ATTN: MOIIRA BARTON PHONE NO : 480-763-5394
10232 SOUTH 51ST ST. SE DECISION MADE: 19-MAR-07
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLIX 120
ALLMED SYSTEMS INC. 510(k) NO: K070476(SPECIAL)
ATTN: PETER ALLEN PHONE NO : 925-468-0433
9232 KLEMETSON DRIVE SE DECISION MADE: 26-MAR-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHA BIO DENTAL IMPLANT SYSTEM
ALPHA-BIO TEC LTD 510(k) NO: K063364(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548
5335 WISCONSIN AVE. NW SE DECISION MADE: 14-MAR-07
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20015
DEVICE: ALPHA BIO BONE FIXATION SCREW SYSTEM
ALPHA-BIO TEC LTD 510(k) NO: K063769(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548
5335 WISCONSIN AVE. NW SE DECISION MADE: 30-MAR-07
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20015
DEVICE: ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
ALPHA-BIO TEC LTD 510(k) NO: K063770(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548
5335 WISCONSIN AVE. NW SE DECISION MADE: 26-MAR-07
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20015
DEVICE: NIGHT GUARD
ALPINE ORAL CARE, LLC 510(k) NO: K061122(TRADITIONAL)
ATTN: CATHY TENG PHONE NO : 713-223-8899
4003 LEELAND SE DECISION MADE: 12-MAR-07
HOUSTON, TX 77003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG CABLES, TRUNK AND PATIENT LEAD WIRES
AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K070232(ABBREVIATED)
ATTN: JOHN TAYLOR PHONE NO : 410-787-1300
7485 SHIPLEY AVE. SE DECISION MADE: 27-MAR-07
HARMANS, MD 21077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K070342(TRADITIONAL)
ATTN: JOHN TAYLOR PHONE NO : 414-787-1300
7485 SHIPLEY AVE. SE DECISION MADE: 19-MAR-07
HARMANS, MD 21077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS SINGLE INCISION SLING SYSTEM (SIS-0)
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K070065(SPECIAL)
ATTN: BRAD ONSTAD PHONE NO : 952-933-6139
10700 BREN RD., WEST SE DECISION MADE: 01-MAR-07
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K070378(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 09-MAR-07
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
ANIMAS CORP. 510(k) NO: K063674(TRADITIONAL)
ATTN: AMY SMITH PHONE NO : 610-644-8990
200 LAWRENCE DR. SE DECISION MADE: 30-MAR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
APOZA ENTERPRISE CO. LTD. 510(k) NO: K070373(SPECIAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340
2904 N. BOLDT DR. SE DECISION MADE: 02-MAR-07
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGON CONTINUOUS FLUSH DEVICE
ARGON MEDICAL DEVICES INC. 510(k) NO: K070384(TRADITIONAL)
ATTN: AMY WINDHAM PHONE NO : 903-675-9321
1445 FLAT CREEK RD. SE DECISION MADE: 29-MAR-07
ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX CROSSPIN, MODEL AR-1964P
ARTHREX, INC. 510(k) NO: K063719(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 06-MAR-07
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAP-NT CHOLESTEROL TEST
ATHEROTECH, INC. 510(k) NO: K062026(TRADITIONAL)
ATTN: REBECCA K PINE PHONE NO : 760-798-2274
15217 SPRINGDALE STREET SE DECISION MADE: 06-MAR-07
HUNTINGTON BEACH, CA 92649 510(k) STATEMENT
DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE
ATLANTIS COMPONENTS, INC. 510(k) NO: K063734(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 02-MAR-07
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS SPINE VERTEBRAL BODY REPLACEMENT
ATLAS SPINE INC. 510(k) NO: K063464(TRADITIONAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-354-4319
1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 09-MAR-07
JUPITER, FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM PROLITE ULTRA S MESH
ATRIUM MEDICAL CORP. 510(k) NO: K070192(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 08-MAR-07
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MO
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K063347(TRADITIONAL)
ATTN: ERICA CONWAY PHONE NO : 44 13 824
THE TECHNOLOGY PARK SE DECISION MADE: 20-MAR-07
DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER PROFOCUS, MODEL 2202
B-K MEDICAL APS 510(k) NO: K070077(TRADITIONAL)
ATTN: VILLY BRAENDER PHONE NO : 011 45 44528100
MILEPARKEN 34 SE DECISION MADE: 05-MAR-07
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FISSO HOLDING SYSTEM
BAITELLA AG 510(k) NO: K070509(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 22-MAR-07
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO 5MP-21 AND MDNG-5121 CB
BARCOVIEW 510(k) NO: K062621(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 19-MAR-07
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
BAUSCH & LOMB, INC. 510(k) NO: K063694(SPECIAL)
ATTN: NANETTE CANEPA PHONE NO : 909-971-5394
180 VIA VERDE DR. SE DECISION MADE: 07-MAR-07
SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPEATER PUMP II TUBE SETS
BAXA CORP. 510(k) NO: K062909(TRADITIONAL)
ATTN: KIMBERLY ZIZIK PHONE NO : 303-617-2242
14445 GRASSLANDS DR. SE DECISION MADE: 09-MAR-07
ENGLEWOOD, CO 80112-7062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA LOW PROFILE RONGEUR
BAXANO, INC. 510(k) NO: K062711(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON ROAD SE DECISION MADE: 07-MAR-07
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD DIRECTIGEN EZ FLU A+B TEST
BECTON DICKINSON & CO. 510(k) NO: K063689(TRADITIONAL)
ATTN: DAINELLE N CLARK PHONE NO : 410-316-4905
7 LOVETON CIR. SE DECISION MADE: 07-MAR-07
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD HYPOINT NEEDLE
BECTON DICKINSON & CO. 510(k) NO: K070440(SPECIAL)
ATTN: AILEEN C GILBERT PHONE NO : 201-847-7197
1 BECTON DR. SE DECISION MADE: 16-MAR-07
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MINOCYCLINE (GN)
BECTON, DICKINSON & CO. 510(k) NO: K063486(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 07-MAR-07
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM
BIO-MEDICAL REASEARCH LTD. 510(k) NO: K070142(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 774300
PARKMORE BUSINESS PARK WEST SE DECISION MADE: 23-MAR-07
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE
BIO-RAD LABORATORIES 510(k) NO: K063866(TRADITIONAL)
ATTN: DAVID BHEND PHONE NO : 425-881-8300
6565 185TH AVE, NE SE DECISION MADE: 19-MAR-07
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIESSE LARYNGEAL IMPLANT
BIOFORM MEDICAL, INC. 510(k) NO: K070090(SPECIAL)
ATTN: JAMES MILLER PHONE NO : 650-286-4040
1875 SOUTH GRANT ST.,SUITE 11O SE DECISION MADE: 01-MAR-07
SAN MATEO, CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
BIOMET MANUFACTURING CORP. 510(k) NO: K062994(SPECIAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 09-MAR-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
BIOMET, INC. 510(k) NO: K070369(SPECIAL)
ATTN: ROBERT FRIDDLE PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 09-MAR-07
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
BIOSITE INCORPORATED 510(k) NO: K062840(TRADITIONAL)
ATTN: FIL V BUENVIAJE PHONE NO : 858-805-2722
9975 SUMMERS RIDGE RD SE DECISION MADE: 01-MAR-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM
BLUE SKY BIO, LLC 510(k) NO: K063874(TRADITIONAL)
ATTN: MICHELE VOVOLKA PHONE NO : 847-548-8499
888 E BELVIDERE RD. SE DECISION MADE: 29-MAR-07
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
GRAYSLAKE, IL 60030
DEVICE: UNITY ALPHA SYSTEM
BONUTTI RESEARCH, INC. 510(k) NO: K062820(TRADITIONAL)
ATTN: PATRICK G BALSMANN PHONE NO : 217-343-3412
2600 SOUTH RANEY SE DECISION MADE: 15-MAR-07
P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA
EFFINGHAM, IL 62401
DEVICE: MODIFICATION TO POLAR CARE 500
BREG, INC. 510(k) NO: K070402(SPECIAL)
ATTN: KATHLEEN BARBER PHONE NO : 760-599-5719
2611 COMMERCE WAY SE DECISION MADE: 29-MAR-07
VISTA, CA 92083 510(k) STATEMENT
DEVICE: ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
BRIGHT ELEMENT SDN BHD 510(k) NO: K063776(TRADITIONAL)
ATTN: SEOW LAW AUDIE PHONE NO : 603 339 28588
NO 5, JALAN USJ 3B/2 SE DECISION MADE: 02-MAR-07
SUBANG JAYA, SELANGOR, MALAYSIA 4510(k) STATEMENT
DEVICE: AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
C.R. BARD, INC. 510(k) NO: K063712(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 678-342-4920
13183 HARLAND DRIVE SE DECISION MADE: 12-MAR-07
COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIGN URETHRAL SUPPORT SYSTEM
C.R. BARD, INC. 510(k) NO: K070073(TRADITIONAL)
ATTN: JULIE J BASSETT PHONE NO : 678-342-4921
13183 HARLAND DRIVE SE DECISION MADE: 21-MAR-07
COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6
C.R. BARD, INC. 510(k) NO: K070508(TRADITIONAL)
ATTN: MICHELLE GUDITH PHONE NO : 770-784-6722
8195 INDUSTRIAL BLVD. SE DECISION MADE: 09-MAR-07
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: C.T.M. MOBILITTY SCOOTER # HS-295
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K070603(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541-345-5431
29611 SIMMONS ROAD SE DECISION MADE: 20-MAR-07
EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADWELL EASYNET OXIMETER MODULE
CADWELL LABORATORIES, INC. 510(k) NO: K061706(TRADITIONAL)
ATTN: CHRIS BOLKAN PHONE NO : 509-735-6481
909 NORTH KELLOGG ST. SE DECISION MADE: 05-MAR-07
KENNEWICK, WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI
CAMSIGHT CO., INC. 510(k) NO: K063646(TRADITIONAL)
ATTN: JAY CHOI PHONE NO : 323-259-1900
3380 SAN FERNADO ROAD SE DECISION MADE: 07-MAR-07
LOS ANGELES, CA 90065 510(k) STATEMENT
DEVICE: BIOMARC GOLD TISSUE MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K070436(SPECIAL)
ATTN: ROBERT W JOHNSON PHONE NO : 651-762-2146
1290 HAMMOND RD. SE DECISION MADE: 16-MAR-07
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVACOAT SINUS GEL AND STENT
CARBYLAN BIOSURGERY 510(k) NO: K070496(SPECIAL)
ATTN: ROXANNE DUBOIS PHONE NO : 650-855-6775
3181 PORTER DRIVE SE DECISION MADE: 15-MAR-07
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
CARDICA, INC. 510(k) NO: K070548(SPECIAL)
ATTN: TIFFINI LALUDE PHONE NO : 650-331-7153
900 SAGINAW DR. SE DECISION MADE: 29-MAR-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MO
CARDIOMEMS INC 510(k) NO: K070448(ABBREVIATED)
ATTN: GRACE POWERS PHONE NO : 404-920-6719
75 FIFTH ST., NW SE DECISION MADE: 15-MAR-07
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30308
DEVICE: BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 5
CARDIVA MEDICAL, INC. 510(k) NO: K070485(SPECIAL)
ATTN: MICHAEL J BILLIG PHONE NO : 408-400-0856
155 MOFFETT PARK DR., SE DECISION MADE: 22-MAR-07
SUITE A-101 510(k) SUMMARY AVAILABLE FROM FDA
SUNNYVALE, CA 94089
DEVICE: XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 90
CEPHEID 510(k) NO: K061062(TRADITIONAL)
ATTN: RUSSEL K ENNS, PH.D. PHONE NO : 408-400-8230
904 CARIBBEAN DRIVE SE DECISION MADE: 09-MAR-07
SUNNYVALE, CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERNER PROVISION WORKSTATION
CERNER CORP. 510(k) NO: K070394(TRADITIONAL)
ATTN: SHELLEY S LOOBY PHONE NO : 816-201-1368
2800 ROCKCREEK PKWY. SE DECISION MADE: 27-MAR-07
KANSAS CITY, MO 64117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTBOX CERVICAL/LUMBAR TRACTION
CIRCULAR TRACTION SUPPLY, INC. 510(k) NO: K063353(TRADITIONAL)
ATTN: DONALD W MEYER PHONE NO : 714-847-8334
7602 TALBERT AVENUE, UNIT #9 SE DECISION MADE: 14-MAR-07
HUNTINGTON BEACH, CA 92648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CISBIO RENIN RIA TEST
CIS BIO INTERNATIONAL 510(k) NO: K062120(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE ROAD SE DECISION MADE: 30-MAR-07
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: CO2 LASER SYSTEM, MODEL C-LAS
CLINICON CORP. 510(k) NO: K063698(TRADITIONAL)
ATTN: KIM BLOOM PHONE NO : 858-675-8200
16787 BERNARDO CENTER DR. SE DECISION MADE: 02-MAR-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: MODIFICATION TO COLLAWOUND DRESSING
COLLAMATRIX CO., INC. 510(k) NO: K070269(SPECIAL)
ATTN: DENNIS J SEAH PHONE NO : 886 277 209988
NO. 360 RUIGUANG ROAD, 2ND FL. SE DECISION MADE: 02-MAR-07
NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: CONCEIVEX CONCEPTION KIT
CONCEIVEX INC. 510(k) NO: K063227(TRADITIONAL)
ATTN: BLIX WINSTON PHONE NO : 301-607-9185
2600 MULLINIX MILL ROAD SE DECISION MADE: 14-MAR-07
MT. AIRY, MD 21771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFORMIS METAL BACKED TIBIAL COMPONENT("MBT")
CONFORMIS, INC. 510(k) NO: K063432(TRADITIONAL)
ATTN: MICHAEL SHARP PHONE NO : 650-292-3636
323-C VINTAGE PARK DR. SE DECISION MADE: 16-MAR-07
FOSTER CITY, CA 94404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,2
CONMED LINVATEC BIOMATERIALS 510(k) NO: K063588(TRADITIONAL)
ATTN: PAIVI MESIRANTA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 02-MAR-07
HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON
CORDIS EUROPA, N.V. 510(k) NO: K063563(TRADITIONAL)
ATTN: JOAN MARTIN PHONE NO : 908-412-7250
7 POWDER HORN DRIVE SE DECISION MADE: 07-MAR-07
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
CORDIS NEUROVASCULAR, INC. 510(k) NO: K070279(SPECIAL)
ATTN: ROBERTO F REFECA PHONE NO : 786-313-2850
14000 N.W. 57TH CT. SE DECISION MADE: 14-MAR-07
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTERA ER:YSGG LASER HANDPIECE
CUTERA, INC. 510(k) NO: K063867(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 415-657-5586
3240 BAYSHORE BLVD SE DECISION MADE: 27-MAR-07
BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTERA ER:YAG LASER HANDPIECE
CUTERA, INC. 510(k) NO: K070138(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 415-657-5586
3240 BAYSHORE BLVD SE DECISION MADE: 27-MAR-07
BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONDEMAND3D
CYBERMED, INC. 510(k) NO: K070464(TRADITIONAL)
ATTN: SONG N CHOI PHONE NO : 822 339 73970
#504 SJ TECHNOVILLE, SE DECISION MADE: 16-MAR-07
GASAN-DONG 60-19, GEUMCHEON-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 153-710 THIRD PARTY REVIEW
DEVICE: STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
DADE BEHRING, INC. 510(k) NO: K063356(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 23-MAR-07
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBR
DADE BEHRING, INC. 510(k) NO: K063663(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 21-MAR-07
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K063756(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 19-MAR-07
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: TOP FINE INSULIN SYRINGE
DAEJIN TECH MEDICAL MANUFACTURING 510(k) NO: K063348(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 01-MAR-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOP FINE
DAEJIN TECH MEDICAL MANUFACTURING 510(k) NO: K063466(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 02-MAR-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENS
DEGANIA SILICONE, LTD. 510(k) NO: K063442(TRADITIONAL)
ATTN: ZOYA LEE PHONE NO : 972 4 670533
DEGANIA BET SE DECISION MADE: 26-MAR-07
EMEK HAYARDEN, ISRAEL 15130 510(k) STATEMENT
DEVICE: ALPHA-CORE DC
DENTAL TECHNOLOGIES, INC. 510(k) NO: K070191(TRADITIONAL)
ATTN: JANINE RAUHUT PHONE NO : 847-677-5500
6901 NORTH HAMLIN AVE. SE DECISION MADE: 07-MAR-07
LINCOLNWOOD, IL 60712 510(k) STATEMENT
DEVICE: PAINT- ON POLISH AGENT
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K070306(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 22-MAR-07
W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
DENTSPLY INTL. 510(k) NO: K070538(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 14-MAR-07
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMOR
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K063633(TRADITIONAL)
ATTN: STEVEN J WENTWORTH PHONE NO : 574-371-4913
700 ORTHOPAEDIC DR. SE DECISION MADE: 02-MAR-07
P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY ASR TAPER SLEEVE ADAPTER
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K070359(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 06-MAR-07
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
DIAMICS, INC. 510(k) NO: K062433(TRADITIONAL)
ATTN: PETER GOMBRICH PHONE NO : 415-883-0414
SIX HAMILTON LANDING SUITE 200 SE DECISION MADE: 16-MAR-07
NOVATO, CA 94949 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
DIGIRAD CORP. 510(k) NO: K070542(SPECIAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600
13950 STOWE DRIVE SE DECISION MADE: 23-MAR-07
POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL ETCH BONDING AGENT
DMG USA, INC. 510(k) NO: K063444(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 20-MAR-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TCA 5R / 5S
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K070123(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 09-MAR-07
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHI
DUKAL CORP. 510(k) NO: K070407(TRADITIONAL)
ATTN: PATRICK J LAMB PHONE NO : 631-656-3800
5 PLANT AVE SE DECISION MADE: 26-MAR-07
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREQUENCER, MODEL 1001
DYMEDSO INC. 510(k) NO: K063645(TRADITIONAL)
ATTN: JEAN BIGONEY PHONE NO : 802-885-8026
127 MAIN ST. SE DECISION MADE: 15-MAR-07
SPRINGFIELD, VT 05156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX ,
E.C.I. USA CORPORATION 510(k) NO: K062873(TRADITIONAL)
ATTN: JAMES WANG PHONE NO : 314-432-5656
544 FAIRWAYS CIRCLE SE DECISION MADE: 20-MAR-07
SAINT LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TU
EDWARDS LIFESCIENCES SERVICES GMBH510(k) NO: K063293(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 44 176 3222505
BUSINESS & TECHNOLOGY CENTER SE DECISION MADE: 23-MAR-07
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE, HERTSFORDSHIRE, UNITED KINGDOM SG1 2DX
DEVICE: DERMA YAG
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K062762(TRADITIONAL)
ATTN: ANDREA TOZZI PHONE NO : 055 882 6807
17 VIA BALDANZESE SE DECISION MADE: 01-MAR-07
CALENZANO, ITALY 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEKSELL GAMMA KNIFE PERFEXION
ELEKTA INSTRUMENT AB 510(k) NO: K063512(TRADITIONAL)
ATTN: ANDERS SKOGLUND PHONE NO : 46 8 58725400
KUNGSTENSGATAN 18 SE DECISION MADE: 05-MAR-07
PO BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA
STOCKHOLM, SWEDEN SE-103 93
DEVICE: CLAROS DENTAL LASER SYSTEM
ELEXXION AG 510(k) NO: K063152(ABBREVIATED)
ATTN: JOHANNES MUELLER PHONE NO : 49 608 1443414
GROOSE LACHE 5 SE DECISION MADE: 07-MAR-07
WHERHEIM, GERMANY 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
ENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K062875(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 425-307-9200
8210 154TH AVE. NE SE DECISION MADE: 09-MAR-07
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERCHONIA IOTO_240
ERCHONIA MEDICAL, INC. 510(k) NO: K062792(TRADITIONAL)
ATTN: KEVIN WALLS,RAC PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 01-MAR-07
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
EST. ANTHOGYR 510(k) NO: K070084(SPECIAL)
ATTN: ERIC GENEVE PHONE NO : 33 045 0580237
164 RUE DES TROIS LACS SE DECISION MADE: 08-MAR-07
SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH NOVATION CROWN CUP AND LINERS
EXACTECH, INC. 510(k) NO: K070479(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 15-MAR-07
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
FALL PREVENTION TECHNOLOGIES, LLC 510(k) NO: K070729(TRADITIONAL)
ATTN: FRANK SCARPINO PHONE NO : 937-434-5455
4601 GATEWAY CIRCLE SE DECISION MADE: 30-MAR-07
KETTERING, OH 45440 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03,
FLAEM NUOVA S.P.A. 510(k) NO: K062014(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 22-MAR-07
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 400
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K070177(SPECIAL)
ATTN: JANET C KAY PHONE NO : 781-699-4475
920 WINTER ST. SE DECISION MADE: 29-MAR-07
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON MODEL EG-530N TRANS NASAL INSERTION
FUJINON, INC. 510(k) NO: K063316(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 16-MAR-07
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-
FUJINON, INC. 510(k) NO: K063847(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 01-MAR-07
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISIS
GALIL MEDICAL LTD. 510(k) NO: K070482(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 20-MAR-07
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRADIA DIRECT X
GC AMERICA INC. 510(k) NO: K070190(TRADITIONAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105
3737 WEST 127TH STREET SE DECISION MADE: 12-MAR-07
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: COE SOFT
GC AMERICA, INC. 510(k) NO: K070697(SPECIAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 29-MAR-07
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: COE COMFORT
GC AMERICA, INC. 510(k) NO: K070698(SPECIAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 29-MAR-07
ALSIP, IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PET VCAR
GE HEALTHCARE 510(k) NO: K063324(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD W 1140 SE DECISION MADE: 23-MAR-07
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH
GE HEALTHCARE 510(k) NO: K070421(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 13-MAR-07
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K062976(SPECIAL)
ATTN: LISA M BAUMHARDT PHONE NO : 414-362-3242
8200 WEST TOWER AVE. SE DECISION MADE: 16-MAR-07
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADRA BLOC TENS, MODEL 101
GRADIENT TECHNOLOGIES, LLC 510(k) NO: K062547(TRADITIONAL)
ATTN: JOHN TOWNSEND PHONE NO : 901-767-2384
6000 POPLAR AVENUE SE DECISION MADE: 21-MAR-07
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
MEMPHIS, TN 38119
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK
GX CORPORATION SDN BHD 510(k) NO: K070096(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 14-MAR-07
JALAN KAPAR 510(k) SUMMARY AVAILABLE FROM FDA
KLANG, MALAYSIA 42100
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE
GX CORPORATION SDN BHD 510(k) NO: K070097(TRADITIONAL)
ATTN: FOO K PU PHONE NO : 603 329 16100
LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 23-MAR-07
JALAN KAPAR 510(k) STATEMENT
KLANG, MALAYSIA 42100
DEVICE: HASELMEIER PEN
HASELMEIER SARL 510(k) NO: K070100(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 240-674-7196
517 BENFIELD ROAD SE DECISION MADE: 21-MAR-07
SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA
SEVERNA PARK, MD 21146-2596
DEVICE: MODIFICATION TO HEALTH BUDDY APPLIANCE
HEALTH HERO NETWORK, INC. 510(k) NO: K070543(SPECIAL)
ATTN: ROBIN BUSH PHONE NO : 650-779-9191
2000 SEAPORT BLVD, SUITE 400 SE DECISION MADE: 28-MAR-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K070489(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST. SE DECISION MADE: 14-MAR-07
HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K070493(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST. SE DECISION MADE: 23-MAR-07
HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
HONG DI PLASTIC PRODUCTS CO, LTD. 510(k) NO: K070188(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 19-MAR-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCA CONSTRAINED ACETABULAR LINERS
HOWMEDICA OSTEONICS CORP 510(k) NO: K063445(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 08-MAR-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 12 CONSTRAINED ACETABULAR LINERS
HOWMEDICA OSTEONICS CORP 510(k) NO: K063550(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 08-MAR-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIES II CONSTRAINED ACETABULAR LINERS
HOWMEDICA OSTEONICS CORP 510(k) NO: K063552(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 08-MAR-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER FOOT PLATING SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K063875(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 15-MAR-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
HOYA CONBIO, INC 510(k) NO: K063384(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209-586-0416
19722 WESTVIEW DRIVE SE DECISION MADE: 16-MAR-07
TWAIN HARTE, CA 95383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROS
ICU MEDICAL, INC 510(k) NO: K070532(SPECIAL)
ATTN: MARTIN MAIER PHONE NO : 801-264-1438
4455 ATHERTON DR. SE DECISION MADE: 20-MAR-07
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
IMPEDIMED PTY LTD. 510(k) NO: K050415(TRADITIONAL)
ATTN: NEVILLE BERTWISTLE PHONE NO : 617 342 31777
BUILDING 4B/2404 LOGAN ROAD SE DECISION MADE: 30-MAR-07
EIGHT MILE PLAINS 510(k) SUMMARY AVAILABLE FROM FDA
BRISBANE, QUEENSLAND, AUSTRALIA 4113
DEVICE: CONICAL ANGLED ABUTMENT
IMPLANT INNOVATIONS, INC. 510(k) NO: K063403(TRADITIONAL)
ATTN: TAMARA NELSON PHONE NO : 561-776-6923
4555 RIVERSIDE DR. SE DECISION MADE: 20-MAR-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANT SCIENCES CORP. MODEL HDR 4454
IMPLANT SCIENCES CORP. 510(k) NO: K070468(SPECIAL)
ATTN: MATTHEW HOLLOWS PHONE NO : 781-246-0700
107 AUDUBON ROAD, #5 SE DECISION MADE: 23-MAR-07
WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URINE CHEMISTRY ANALYZER UR-50
IND DIAGNOSTIC INC. 510(k) NO: K063390(TRADITIONAL)
ATTN: BRIAN LEMAY PHONE NO : 321-299-2521
P.O. BOX 162 SE DECISION MADE: 01-MAR-07
ALTAMONTE SPRINGS, FL 32716 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
INNOVACON, INC. 510(k) NO: K063673(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4106 SORRENTO VALLEY BLVD. SE DECISION MADE: 05-MAR-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EARCHECK ACOUSTIC REFLECTOMETER
INNOVIA MEDICAL, LLC 510(k) NO: K070312(SPECIAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 02-MAR-07
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: QUANTA LITE H-TTG/DGP SCREEN
INOVA DIAGNOSTICS, INC. 510(k) NO: K070083(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 12-MAR-07
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: HEMOSIL PROCLOT
INSTRUMENTATION LABORATORY CO. 510(k) NO: K070635(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 29-MAR-07
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #85
INVERNESS MEDICAL PROFESSIONAL DIA510(k) NO: K070522(SPECIAL)
ATTN: KAREN MORTIMER PHONE NO : 207-730-5705
10 SOUTHGATE RD. SE DECISION MADE: 15-MAR-07
SCARBOROUGH, ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IM
IRVINE BIOMEDICAL,INC.(IBI) 510(k) NO: K070011(TRADITIONAL)
ATTN: ROHIT PATEL PHONE NO : 949-271-1127
2375 MORSE AVE. SE DECISION MADE: 20-MAR-07
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS DIODE LASER
IVOCLAR VIVADENT, INC. 510(k) NO: K062258(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DRIVE SE DECISION MADE: 21-MAR-07
AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREATION CP-ZI PORCELAIN
JENSEN INDUSTRIES, INC. 510(k) NO: K070114(ABBREVIATED)
ATTN: GARY PHELPS PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 01-MAR-07
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOYKEY SURGICAL GOWNS (STERILE)
JOYKEY INDUSTRYIAL LTD. 510(k) NO: K062479(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-853-6340
2904 N. BOLDT DRIVE SE DECISION MADE: 14-MAR-07
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOYKEY SURGICAL DRAPES (STERILE)
JOYKEY INDUSTRYIAL LTD. 510(k) NO: K062480(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-853-6340
2904 N. BOLDT DRIVE SE DECISION MADE: 05-MAR-07
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, M
KEVIN VU, DDS 510(k) NO: K070127(TRADITIONAL)
ATTN: GLEN FEYE PHONE NO : 619-517-1762
1340 WEST PENNSYLVANIA AVE. SE DECISION MADE: 29-MAR-07
SAN DIEGO, CA 92103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BP 101 DIGITAL BLOOD PRESSURE MONITOR
KING YIELD HONGKONG LIMITED 510(k) NO: K062033(TRADITIONAL)
ATTN: DACHENG GONG PHONE NO : 867 552 7371997
12 FL, NO. 180 ELECTRIC ROAD SE DECISION MADE: 23-MAR-07
NORTH POINT, HONG KONG 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K062659(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO : 781-834-6600
180 ENTERPRISE DR. SE DECISION MADE: 09-MAR-07
MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERI
KLS MARTIN L.P. 510(k) NO: K070169(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 26-MAR-07
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: CLEARFIL MAJESTY ESTHETIC PLT
KURARAY MEDICAL INC. 510(k) NO: K070325(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
600 LEXINGTON AVENUE SE DECISION MADE: 21-MAR-07
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSOR
LASERING S.R.L. 510(k) NO: K063001(TRADITIONAL)
ATTN: ALLEN R HOWES PHONE NO : 925-355-0750
2246 CAMINO RAMON SE DECISION MADE: 07-MAR-07
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LERADO, POWER WHEELCHAIR, PB
LERADO CHINA LIMITED 510(k) NO: K070433(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 16-MAR-07
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LMT-KATH-S; LMT-KATH-I
LICHER MEDIZINTECHNOLOGIE GMBH 510(k) NO: K062308(ABBREVIATED)
ATTN: DIETER MUSHOFF PHONE NO : 011 49 51305855
MARDERWEG 1 SE DECISION MADE: 20-MAR-07
WEDEMARK, GERMANY D-30900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM
LIFE SPINE 510(k) NO: K070285(TRADITIONAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117
2400 HASSELL ROAD SE DECISION MADE: 13-MAR-07
SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60169
DEVICE: LIV BREAST SELF EXAMINATION AID
LIV INTERNATIONAL USA, INC. 510(k) NO: K070344(TRADITIONAL)
ATTN: PARTICK GORA PHONE NO : 507-269-2895
5811 PARTRIDGE DRIVE SW SE DECISION MADE: 08-MAR-07
ROCHESTER, MN 55902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE NITRILE BLUE EXAMINATION GLOVE
LIWE TRADING 510(k) NO: K061504(TRADITIONAL)
ATTN: K M LEE PHONE NO : 033 392 1992
49,JALAN SS 2/19 SE DECISION MADE: 19-MAR-07
47300 PETALING JAYA 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 47300
DEVICE: MA 55 "MAESTRO"
MAICO DIAGNOSTICS (DIAGNOSTIC GROU510(k) NO: K063452(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-278-4457
7625 GOLDEN TRIANGLE D SE DECISION MADE: 29-MAR-07
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: POWERLED SURGICAL LIGHT SYSTEM
MAQUET S.A. 510(k) NO: K070442(SPECIAL)
ATTN: KEVIN M TOMPKINS PHONE NO : 585-272-5078
1777 EAST HENRIETTA RD. SE DECISION MADE: 16-MAR-07
ROCHESTER, NY 14623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDIANCATHETER-URINARY DRAINAGE CATHETER
MARIAN MEDICAL, INC. 510(k) NO: K063795(TRADITIONAL)
ATTN: SANDRA WINKLER PHONE NO : 502-552-6189
319 WESTPORT DR. SE DECISION MADE: 05-MAR-07
LOUISVILLE, KY 40207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
MARIAN MEDICAL, INC. 510(k) NO: K070048(TRADITIONAL)
ATTN: SANDRA WINKLER PHONE NO : 502-552-6189
319 WESTPORT DR. SE DECISION MADE: 15-MAR-07
LOUISVILLE, KY 40207 510(k) STATEMENT
DEVICE: SURGI-WRAP MAST TENDON SHEET
MAST BIOSURGERY USA INC. 510(k) NO: K063648(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6749 TOP GUN ST., SUITE C SE DECISION MADE: 07-MAR-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXHEALTH MECHANICAL WHEELCHAIR, K1
MAXHEALTH CORP. 510(k) NO: K070176(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 01-MAR-07
HSIN-CHU CITY,, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
MEDICAL ELECTRONIC SYSTEMS LTD. 510(k) NO: K063864(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768
575 SHIRLYNN CT. SE DECISION MADE: 26-MAR-07
LOS ALTOS, CA 94022 510(k) STATEMENT
DEVICE: ATRILAZE MI SURGICAL ABLATION SYSTEM
MEDICALCV, INC. 510(k) NO: K061489(ABBREVIATED)
ATTN: DENNY STEGER PHONE NO : 651-452-3000
9725 SOUTH ROBERT TRAIL SE DECISION MADE: 16-MAR-07
INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECONOLITH EM1000
MEDISPEC, LTD. 510(k) NO: K063504(TRADITIONAL)
ATTN: ANIL DHINGRA PHONE NO : 301-944-1575
12850 MIDDLEBROOK RD. STE. 1 SE DECISION MADE: 09-MAR-07
GERMANTOWN, MD 20874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
MEDRAD, INC. 510(k) NO: K063090(TRADITIONAL)
ATTN: TROY A JACK PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 27-MAR-07
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BANANA RIBBED
MEDTECH PRODUCTS LTD. 510(k) NO: K063401(ABBREVIATED)
ATTN: RAVI REDDY PHONE NO : 425-641-5192
5876 155TH AVE. S.E. SE DECISION MADE: 26-MAR-07
BELLEVUE, WA 98006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINA
MEDTEXX MANUFACTURING SDN. BHD. 510(k) NO: K070072(TRADITIONAL)
ATTN: OOI LOON SENG (MDM) PHONE NO : 605 891 1111
PT 4004 KAMUNTING INDU. ESTATE SE DECISION MADE: 15-MAR-07
KAMUNTING, TAIPING, PERAK, MALAYSI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478
MEDTRONIC INC., CARDIAC RHYTHM MAN510(k) NO: K063210(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-505-7263
1015 GRAMSIE RD SE DECISION MADE: 15-MAR-07
SHOREVIEW, MN 55126-3082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCUATE VERTEBRAL AUGMENTATION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K063248(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 13-MAR-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 SCEPTOR SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K063491(TRADITIONAL)
ATTN: CHRISTINE SEIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 05-MAR-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K070173(SPECIAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 14-MAR-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC PERFORMER CPB, MODEL R51/PCPB
MEDTRONIC, INC. 510(k) NO: K070213(TRADITIONAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9533
7611 NORTHLAND DR. SE DECISION MADE: 21-MAR-07
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEMOMETAL MEMORY STAPLES
MEMOMETAL TECHNOLOGIES 510(k) NO: K070031(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 33 2 99055969
RUE BLAISE PASCAL SE DECISION MADE: 19-MAR-07
CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA
BRUZ, FRANCE F35170
DEVICE: MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-
MEMOMETAL TECHNOLOGIES 510(k) NO: K070033(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 33 2 99055969
RUE BLAISE PASCAL SE DECISION MADE: 19-MAR-07
CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA
BRUZ, FRANCE F35170
DEVICE: MEMOMETAL FIXOS SCREWS
MEMOMETAL TECHNOLOGIES 510(k) NO: K070039(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 33 2 99055969
RUE BLAISE PASCAL SE DECISION MADE: 21-MAR-07
CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA
BRUZ, FRANCE F35170
DEVICE: SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
MODERN HEALTHCARE CORP. 510(k) NO: K063043(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 21-MAR-07
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRAR
MONEBO TECHNOLOGIES, INC. 510(k) NO: K062282(TRADITIONAL)
ATTN: DALE J MISCZYNSKI PHONE NO : 512-732-0235
1800 BARTON CREEK BLVD. SE DECISION MADE: 22-MAR-07
AUSTIN, TX 78735-1606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBELT ELECTRODE BELT
MONEBO TECHNOLOGIES, INC. 510(k) NO: K063044(ABBREVIATED)
ATTN: DALE J MISCZYNSKI PHONE NO : 512-732-0235
1800 BARTON CREEK BLVD. SE DECISION MADE: 23-MAR-07
AUSTIN, TX 78735-1606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOORLD12-B1 LASER DOPPLER BURNS IMAGER
MOOR INSTRUMENTS LTD. 510(k) NO: K060976(TRADITIONAL)
ATTN: DAVID BOGGETT PHONE NO : 441 297 35715
MILLWEY SE DECISION MADE: 27-MAR-07
AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MORTARA ELI 10 ELECTROCARDIOGRAPH
MORTARA INSTRUMENT, INC. 510(k) NO: K070539(SPECIAL)
ATTN: LAURA M SPIEGELHOFF PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 15-MAR-07
MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBX DEMINERALIZED BONE MATRIX MIX
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K063676(TRADITIONAL)
ATTN: NANCY BENNEWITZ PHONE NO : 732-661-0202
125 MAY ST, STE 300 SE DECISION MADE: 05-MAR-07
EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
NEKS TECHNOLOGIES, INC. 510(k) NO: K063321(TRADITIONAL)
ATTN: NAIM KARAZIVAN PHONE NO : 450 973 3598
2816, JOSEPH A. BOMBARDIER SE DECISION MADE: 30-MAR-07
LAVAL, QUEBEC, CANADA H7P 6E2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MOD
NEO-GENESIS 510(k) NO: K060452(ABBREVIATED)
ATTN: JANNET BALDWIN PHONE NO : 503-255-3002
4814 N.E. 107TH AVENUE SE DECISION MADE: 13-MAR-07
PORTLAND, OR 97220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWDEAL COMPRESSION PLATE
NEWDEAL SAS 510(k) NO: K070447(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DR. SE DECISION MADE: 29-MAR-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIRCONIA IMPLANT
NOBEL BIOCARE AB 510(k) NO: K061971(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PARKWAY SE DECISION MADE: 06-MAR-07
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS TRIGLYCERIDE TEST SYSTEM
OLYMPUS AMERICA, INC. 510(k) NO: K063804(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-619-4710
3131 WEST ROYAL LN. SE DECISION MADE: 23-MAR-07
IRVING, TX 75063-3104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K063786(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 05-MAR-07
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: ORISON EMBRACE SYSTEM
ORISON CORPORATION 510(k) NO: K070477(TRADITIONAL)
ATTN: JOHN DIXON PHONE NO : 423-946-0629
121 BOONE RIDGE DR. SE DECISION MADE: 09-MAR-07
JOHNSON CITY, TN 37601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
OSTEOMED L.P. 510(k) NO: K063298(TRADITIONAL)
ATTN: DAWN D TINDALL PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 02-MAR-07
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
OSTEOMED L.P. 510(k) NO: K063792(TRADITIONAL)
ATTN: PIEDAD PENA PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 02-MAR-07
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD. 510(k) NO: K070262(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 44 125 6841144
WADE RD. SE DECISION MADE: 14-MAR-07
BASINGSTOKE, HANTS, UNITED KINGDOM510(k) STATEMENT
DEVICE: P&F POWER WHEELCHAIR, HC-510
P&F BROTHER IND.,CORP 510(k) NO: K070350(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST. SE DECISION MADE: 14-MAR-07
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROKABONE, TROKABONE STERNAL
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K070179(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 049 770 49291586
KARL-HALL-STRASSE 1 SE DECISION MADE: 07-MAR-07
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESSWAY INTERMITTENT CATHETER
PERCUTANEOUS SYSTEMS, INCORPORATED510(k) NO: K061766(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650-969-8800
1300 CRITTENDEN LANE SE DECISION MADE: 09-MAR-07
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043
DEVICE: K-Y BRAND WARMING LIQUID
PERSONAL PRODUCTS CO. 510(k) NO: K070545(SPECIAL)
ATTN: NADER FOTOUHI PHONE NO : 908-904-3730
199 GRANDVIEW RD. SE DECISION MADE: 23-MAR-07
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
PHADIA US INC. 510(k) NO: K063775(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVE. SE DECISION MADE: 14-MAR-07
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
PHILIPS MEDICAL SYSTEMS 510(k) NO: K070588(SPECIAL)
ATTN: TAPAN D SHAH PHONE NO : 978-659-7681
3000 MINUTEMAN RD. SE DECISION MADE: 20-MAR-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS ESSENTA DR
PHILIPS MEDICAL SYSTEMS GMBH, DMC 510(k) NO: K070528(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 09-MAR-07
BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PS SERIES
PHOTONIC OPTISCHE GERATE GESMBH & 510(k) NO: K061622(TRADITIONAL)
ATTN: DIETER FEGER PHONE NO : 43 1 4865691
SEEBOCKGASSE 59 SE DECISION MADE: 05-MAR-07
VIENNA, AUSTRIA A-1160 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYST
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K070551(SPECIAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 29-MAR-07
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMOS MODULAR SHOULDER SYSTEM
PLUS ORTHOPEDICS AG 510(k) NO: K063578(TRADITIONAL)
ATTN: PAMELA J WEAGRAFF PHONE NO : 508-528-1745
18 BRIDIE LANE SE DECISION MADE: 02-MAR-07
NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPATCH ENDO-SLEEVE
PM DEVICES, INC. 510(k) NO: K063556(TRADITIONAL)
ATTN: TIM VERSPAGEN PHONE NO : 604 270 4344
13700 MAYFIELD PL. SE DECISION MADE: 20-MAR-07
UNIT 2135 510(k) STATEMENT
RICHMOND, CANADA V6V 2E4
DEVICE: APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
POINTE SCIENTIFIC, INC. 510(k) NO: K061377(TRADITIONAL)
ATTN: WILLIAM WALTERS PHONE NO : 734-487-8310
5449 RESEARCH DRIVE SE DECISION MADE: 28-MAR-07
CANTON, MI 48188 510(k) STATEMENT
DEVICE: SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON
PT MAHAKARYA INTI BUANA 510(k) NO: K063581(TRADITIONAL)
ATTN: V. NADARAJAN PHONE NO : 62 61 7944880
JL.SEI BELUMAI DESA DALU 10A SE DECISION MADE: 15-MAR-07
DUSUN I 510(k) STATEMENT
TANJUNG MORAWA, SUMUT, INDONESIA 20362
DEVICE: R&D SICKLE QC CONTROL
R & D SYSTEMS, INC. 510(k) NO: K070334(TRADITIONAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413
614 MCKINLEY PL., N.E. SE DECISION MADE: 29-MAR-07
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASMACON N, PLASMACON L-1, PLASMACON L-2
R2 DIAGNOSTICS, INC. 510(k) NO: K062306(TRADITIONAL)
ATTN: MARC GOLDFORD PHONE NO : 574-288-4377
1801 COMMERCE DR. SE DECISION MADE: 16-MAR-07
SOUTH BEND, IN 46628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-LOADED VISICOIL
RADIOMED CORPORATION 510(k) NO: K070305(SPECIAL)
ATTN: GORDON ROBERTS PHONE NO : 978-649-0300
ONE INDUSTRIAL WAY SE DECISION MADE: 07-MAR-07
TYNGSBORO, MA 01879-1400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCHEM EXT CHEMICAL INTEGRATOR
RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K062651(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781
8607 PARK DR. SE DECISION MADE: 15-MAR-07
OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: OCU-FILM TIP COVER
REICHERT, INC. 510(k) NO: K070534(SPECIAL)
ATTN: SANDRA BROWN PHONE NO : 716-686-4599
3362 WALDEN AVE. SE DECISION MADE: 27-MAR-07
DEPEW, NY 14043 510(k) STATEMENT
DEVICE: SATURN 3 LASER SYSTEM
RESEARCH INSTRUMENTS LTD. 510(k) NO: K060764(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 12-MAR-07
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMSTAR AFLEX CPAP SYSTEM
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K063830(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 09-MAR-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETRO-TECH DRESSING
RETRO-TECH, LLC 510(k) NO: K060832(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 13-MAR-07
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENGIGEL MOUTHRINSE
RICERFARMA SRL 510(k) NO: K053342(TRADITIONAL)
ATTN: PAUL KETTERIDGE PHONE NO : 410-788-5492
303 PATLEIGH ROAD SE DECISION MADE: 13-MAR-07
CATONSVILLE, MD 21228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT D-DIMER TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K062203(TRADITIONAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 14-MAR-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TDM CONTROL SET, MODEL CAT# 04521536
ROCHE DIAGNOSTICS CORP. 510(k) NO: K070200(SPECIAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 19-MAR-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PTH TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K070391(SPECIAL)
ATTN: KAY TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 20-MAR-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE
RUBICOR MEDICAL, INC. 510(k) NO: K070275(TRADITIONAL)
ATTN: HUGH MAGEN PHONE NO : 650-556-1070
600 CHESAPEAKE DRIVE SE DECISION MADE: 09-MAR-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SAF-T-SYRINGE- 0.5 AND 1ML/CC
SAFETY MEDICAL INTERNATIONAL, INCO510(k) NO: K063340(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 06-MAR-07
BEVERLY, MA 01915 510(k) STATEMENT
DEVICE: BP-200 PLUS
SCHILLER AG 510(k) NO: K063814(TRADITIONAL)
ATTN: RETO KUETTEL PHONE NO : 41 417 664343
ALTGASSE 68 SE DECISION MADE: 07-MAR-07
BAAR, ZG, SWITZERLAND 6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
SCHOELLY IMAGING, INC. 510(k) NO: K060899(TRADITIONAL)
ATTN: BONI S BONNEVILLE PHONE NO : 508-425-6989
173 GROVE STREET SE DECISION MADE: 02-MAR-07
WORCESTER, MA 01605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
SCIENCE FOR BIOMATERIALS 510(k) NO: K070507(SPECIAL)
ATTN: DENIS CLEMENT PHONE NO : 335 624 22101
ZI DU MONGE SE DECISION MADE: 29-MAR-07
LOURDES, FRANCE 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUIKE 3421 POWERED WHEELCHAIR
SHANGHAI RUIKE SPORTS GOODS CO., L510(k) NO: K070501(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2, NO.1, LANE 25 SE DECISION MADE: 22-MAR-07
ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, TAIPEI COUNTY, CHINA (TAIWAN) 220
DEVICE: TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
SHEN WEI (USA), INC. 510(k) NO: K062919(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692
33278 CENTRAL AVE., SE DECISION MADE: 20-MAR-07
SUITE 102 510(k) STATEMENT
UNION CITY, CA 94587
DEVICE: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K070526(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-MAR-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070026(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 07-MAR-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED (WHITE) VINYL PATIENT EXAMINATION
SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070027(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 22-MAR-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070041(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 28-MAR-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOCT
SHINA SYSTEMS LTD. 510(k) NO: K070226(TRADITIONAL)
ATTN: ELI M ORBACH PHONE NO : 972 299 32768
POB 6718 SE DECISION MADE: 09-MAR-07
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX AND LOOP COIL SET 1.5 T
SIEMENS MEDICAL SOLUTIONS 510(k) NO: K070629(TRADITIONAL)
ATTN: HELMUT NEUMANN PHONE NO : 499 131 847445
HENKESTRASSE 127 SE DECISION MADE: 26-MAR-07
ERLANGEN, GERMANY D91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACUSON X150 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K070576(SPECIAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 26-MAR-07
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMO
SMART GLOVE CORP. SDN BHD 510(k) NO: K063627(TRADITIONAL)
ATTN: CHO S FONG PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 20-MAR-07
JALAN KAPAR 510(k) SUMMARY AVAILABLE FROM FDA
KLANG SELANGOR, MALAYSIA 42100
DEVICE: PLC SUTURE ANCHOR
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K063726(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 06-MAR-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURE ARTERIAL BLOOD SAMPLING SYSTEM
SMITHS MEDICAL ASD, INC. 510(k) NO: K070340(TRADITIONAL)
ATTN: BARBARA LAW PHONE NO : 614-791-5568
6250 SHIER RINGS RD. SE DECISION MADE: 15-MAR-07
DUBLIN, OH 40316 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGORA PCT/DIGIPOD
SOREDEX PALODEX GROUP OY 510(k) NO: K070304(TRADITIONAL)
ATTN: KAI LANER PHONE NO : 358 45 78822000
NAHKELANTIE 160 SE DECISION MADE: 27-MAR-07
TUUSULA, FINLAND FIN-04300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
SPACELABS MEDICAL INC. 510(k) NO: K063490(TRADITIONAL)
ATTN: DAVID J GERAGHTY PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 15-MAR-07
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED HEART STABILIZERS AND POSITIONERS
STERILMED, INC. 510(k) NO: K063844(TRADITIONAL)
ATTN: DENNIS TOUSSAINT PHONE NO : 888-856-4870
11140 73RD AVE. NORTH SE DECISION MADE: 15-MAR-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
STOCKERT GMBH 510(k) NO: K070134(SPECIAL)
ATTN: DOMINIKA SCHULER PHONE NO : 49 761 207160
BOETZINGER STRASSE 72 SE DECISION MADE: 22-MAR-07
FREIBURG, B-W, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T6 HOODS AND TOGAS
STRYKER INSTRUMENTS 510(k) NO: K063005(TRADITIONAL)
ATTN: PAULETTE D JOHNSON PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 23-MAR-07
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DALL-MILES SYSTEM
STRYKER ORTHOPAEDICS 510(k) NO: K070170(TRADITIONAL)
ATTN: PATRICIA SETTI-LAPERCH PHONE NO : 201-831-5938
325 CORPORATE DRIVE SE DECISION MADE: 02-MAR-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
STRYKER SPINE 510(k) NO: K063430(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 22-MAR-07
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070038(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 23-MAR-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
SURGICAL INNOVATIONS GROUP PLC 510(k) NO: K070712(SPECIAL)
ATTN: STUART MORAN PHONE NO : 440 113 2307597
CLAYTON PARK CLAYTON WOOD RISE SE DECISION MADE: 28-MAR-07
LEEDS, UNITED KINGDOM LS16,6RF 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA
SURGIQUEST, INC. 510(k) NO: K063859(TRADITIONAL)
ATTN: KOUROSH AZARBARZIN PHONE NO : 203-799-2400
12 CASCADE BLVD. SE DECISION MADE: 14-MAR-07
SUITE 2B 510(k) SUMMARY AVAILABLE FROM FDA
ORANGE, CT 06477
DEVICE: WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK
SURVIVAIR, INC. 510(k) NO: K070139(ABBREVIATED)
ATTN: RICHARD O WOOD PHONE NO : 847-234-7500
1025 W.EVERETT RD. SE DECISION MADE: 02-MAR-07
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL
SUZHOU MEDICAL APPLIANCE FACTORY 510(k) NO: K063568(TRADITIONAL)
ATTN: HENRY WOO PHONE NO : 714-545-3181
1491 BAKER ST. SE DECISION MADE: 22-MAR-07
SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA
COSTA MESA, CA 92626
DEVICE: SYNTERMED LIVE
SYNTERMED, INC. 510(k) NO: K070089(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256
245 OWENS DR. SE DECISION MADE: 02-MAR-07
ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
SYNTHES (USA) 510(k) NO: K062872(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948
1301 GOSHEN PKWY SE DECISION MADE: 13-MAR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
SYNTHES (USA) 510(k) NO: K063473(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948
1301 GOSHEN PKWY SE DECISION MADE: 08-MAR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) ELBOW HINGE FIXATOR
SYNTHES (USA) 510(k) NO: K063832(TRADITIONAL)
ATTN: JENNIFER PERKS PHONE NO : 610-719-6941
1301 GOSHEN PKWY SE DECISION MADE: 07-MAR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
SYNTHES (USA) 510(k) NO: K070208(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY SE DECISION MADE: 28-MAR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELI
SYNTHES (USA) 510(k) NO: K070294(SPECIAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY. SE DECISION MADE: 01-MAR-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
T.O.A.D.S., LLC. 510(k) NO: K063149(TRADITIONAL)
ATTN: DAVID BAUGHMAN PHONE NO : 502-581-8770
1226 ROWAN ST. SE DECISION MADE: 08-MAR-07
LOUISVILLE, KY 40203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SU
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K070472(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 15-MAR-07
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: ELLEX SLIT LAMP, MODEL 30XL
TAKAGI SEIKO CO., LTD. 510(k) NO: K063352(TRADITIONAL)
ATTN: KEVIN HOWARD PHONE NO : 61 8 81045226
82 GILBERT STREET SE DECISION MADE: 13-MAR-07
ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) STATEMENT
DEVICE: OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
TAKIRON CO., LTD 510(k) NO: K061881(TRADITIONAL)
ATTN: KUNIHIRO HATA PHONE NO : 81 6 62672809
405 NAGANO, YASUTOMI-CHO SE DECISION MADE: 14-MAR-07
HIMEJI, JAPAN 671-2421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
TANGSHAN LUXIONG PLASTIC PRODUCTS 510(k) NO: K070404(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
NO. 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 26-MAR-07
HAIDIAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: SEKURIT SHARPS COLLECTION CONTAINER
TECHEN SAFETY, INC. 510(k) NO: K063722(TRADITIONAL)
ATTN: SID MATHUR PHONE NO : 516-482-9001
55 NORTHERN BLVD SE DECISION MADE: 05-MAR-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: TENDERFLOW PERIATRIC ARTERIAL CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K063618(SPECIAL)
ATTN: CHRISTINA L THOMAS PHONE NO : 800-262-3304
6200 JACKSON RD. SE DECISION MADE: 13-MAR-07
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TR BAND
TERUMO MEDICAL CORP. 510(k) NO: K070423(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 28-MAR-07
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
THERMO ELECTRON CORP. 510(k) NO: K061412(TRADITIONAL)
ATTN: BOLA NICHOLSON PHONE NO : 412-747-4039
171 INDUSTRY DRIVE SE DECISION MADE: 23-MAR-07
PITTSBURG, PA 15272 510(k) STATEMENT
DEVICE: COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL
THERMO ELECTRON OY 510(k) NO: K063150(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 329100
RATASTIE 2 SE DECISION MADE: 19-MAR-07
PO BOX 100 510(k) SUMMARY AVAILABLE FROM FDA
VANTAA, FINLAND FIN-01621
DEVICE: HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
THERMO ELECTRON OY 510(k) NO: K063209(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 932 9100
RATASTIE 2 SE DECISION MADE: 21-MAR-07
VANTAA, FINLAND 01620 510(k) STATEMENT
DEVICE: CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
THERMO ELECTRON OY 510(k) NO: K063647(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 32910762
RATASTIE 2 SE DECISION MADE: 12-MAR-07
PO BOX 100 510(k) SUMMARY AVAILABLE FROM FDA
VANTAA, FINLAND FIN-01621
DEVICE: OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
THERMO-ELECTRON CORP. 510(k) NO: K062521(TRADITIONAL)
ATTN: MELITA LAMBIRIS PHONE NO : 613 979 04100
189-199 BROWNS RD. SE DECISION MADE: 16-MAR-07
NOBLE PARK, VICTORIA, AUSTRALIA 31510(k) STATEMENT
DEVICE: PORTI 7 PHYSIOLOGICAL AMPLIFIER
TMS INTERNATIONAL BV 510(k) NO: K063599(SPECIAL)
ATTN: DAVID W WAGNER PHONE NO : 303-674-3070
7744 SWAPS TRAIL SE DECISION MADE: 22-MAR-07
EVERGREEN, CO 80439 510(k) STATEMENT
DEVICE: TOKUYAMA BOND FORCE
TOKUYAMA DENTAL CORPORATION 510(k) NO: K070215(TRADITIONAL)
ATTN: ROBERT A SILVERMAN PHONE NO : 202-783-5070
1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 30-MAR-07
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A
TOTOKU ELECTRIC CO., LTD 510(k) NO: K070370(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469
300 OYA SE DECISION MADE: 09-MAR-07
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTOGRAM, CA3350
TYMPANY, INC. 510(k) NO: K070118(TRADITIONAL)
ATTN: LEX J PEARCE PHONE NO : 801-365-2800
2795 EAST COTTONWOOD PKWY. SE DECISION MADE: 07-MAR-07
SUITE 660 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84121
DEVICE: UNITIP HIGH RESOLUTION CATHETER
UNISENSOR AG 510(k) NO: K062222(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVE. SE DECISION MADE: 15-MAR-07
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K070420(TRADITIONAL)
ATTN: MICHAEL WOLF PHONE NO : 440-639-4494
5976 HEISELY RD. SE DECISION MADE: 19-MAR-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS
VALLEYLAB,A DIVISION OF TYCO HEALT510(k) NO: K070162(TRADITIONAL)
ATTN: PHILIP E AKE PHONE NO : 303-530-6469
5920 LONGBOW DR. SE DECISION MADE: 06-MAR-07
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAN ESOPHAGUS BOUGIE APPLICATOR
VARIAN MEDICAL SYSTEMS 510(k) NO: K063815(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 01-MAR-07
M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129
DEVICE: VARI-LASE BRIGHT TIP FIBER
VASCULAR SOLUTIONS, INC. 510(k) NO: K070216(TRADITIONAL)
ATTN: DEBORAH L NEYMARK PHONE NO : 763-656-4349
6464 SYCAMORE COURT SE DECISION MADE: 16-MAR-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELOCITYAIS
VELOCITY MEDICAL SOLUTIONS, LLC 510(k) NO: K070248(TRADITIONAL)
ATTN: PAUL SUMNER PHONE NO : 770-448-7529
1733 CANTON LANE SE DECISION MADE: 01-MAR-07
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAR VISION 2000
VIDAR SYSTEMS CORP. 510(k) NO: K070563(TRADITIONAL)
ATTN: JAMES M TAYLOR PHONE NO : 802-244-5654
75 ORCHARD SPRING ESTS. SE DECISION MADE: 16-MAR-07
WATERBURY, VT 05676 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
VILEX, INC. 510(k) NO: K070052(TRADITIONAL)
ATTN: ABRAHAM LAVI PHONE NO : 412-655-7550
345 OLD CURRY HOLLOW RD. SE DECISION MADE: 28-MAR-07
PITTSBURGH, PA 15236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
VOLCANO CORPORATION 510(k) NO: K070487(SPECIAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-231-4510
2870 KILGORE RD. SE DECISION MADE: 16-MAR-07
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK TO ACUITY CLINICIAN NOTIFIER
WELCH ALLYN PROTOCOL, INC. 510(k) NO: K070204(SPECIAL)
ATTN: JEFFREY WAGNER PHONE NO : 503-530-7500
8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 23-MAR-07
BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRACHYSCIENCES STRANDPORT
WORLDWIDE MEDICAL TECHNOLOGIES, LL510(k) NO: K062214(TRADITIONAL)
ATTN: WAYNE W RICHARDSON PHONE NO : 203-262-4190
115 HURLEY ROAD BLDG. 3B SE DECISION MADE: 01-MAR-07
OXFORD, CT 06478 510(k) STATEMENT
DEVICE: ADVANCE SPIKED POROUS TIBIAL BASE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K063128(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143
5677 AIRLINE RD. SE DECISION MADE: 21-MAR-07
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE STATURE FEMORAL COMPONENT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K063731(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143
5677 AIRLINE RD. SE DECISION MADE: 02-MAR-07
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K070525(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 847-367-1911
5677 AIRLINE RD. SE DECISION MADE: 29-MAR-07
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOX
X-CEL CONTACTS 510(k) NO: K070308(TRADITIONAL)
ATTN: KEVIN RANDALL PHONE NO : 303-956-8595
581 WHILES COURT SE DECISION MADE: 12-MAR-07
ERIE, CO 80516-4933 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K063186(TRADITIONAL)
ATTN: EWA NADOLCZAK PHONE NO : 908-243-4924
P.O. BOX 38 SE DECISION MADE: 21-MAR-07
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
ZIMMER, INC. 510(k) NO: K070214(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 16-MAR-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIOSTATION
ZIOSOFT, INC. 510(k) NO: K070205(TRADITIONAL)
ATTN: MARC GOODMAN PHONE NO : 714-258-4646
5405 ALTON PARKWAY SE DECISION MADE: 23-MAR-07
SUITE A530 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92604
TOTAL 510(k)s THIS PERIOD 278
TOTAL WITH SUMMARIES 242
TOTAL WITH STATEMENTS 36
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