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Medical Devices
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December 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-DEC-2007 THROUGH 31-DEC-2007
DEVICE: AIR-FLOW MASTER STANDARD
(EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K073284(SPECIAL)
ATTN: SUSAN M BONAPACE PHONE NO : 508-316-7110
49 PLAIN ST. SE DECISION MADE: 14-DEC-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
3T MEDICAL SYSTEMS, LLC 510(k) NO: K072697(TRADITIONAL)
ATTN: ROBERT P EATON PHONE NO : 303-838-2407
12553 S. WAMBLEE VALLEY ROAD SE DECISION MADE: 20-DEC-07
CONIFER, CO 80433 510(k) STATEMENT
DEVICE: DIVO
A2D IMAGING LLC 510(k) NO: K072637(TRADITIONAL)
ATTN: DON WAUCHOPE PHONE NO : 818-324-2871
17271 LIDO LANE SE DECISION MADE: 11-DEC-07
HUNTINGTON BEACH, CA 92647 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
ABIOMED, INC. 510(k) NO: K070225(TRADITIONAL)
ATTN: ROBERT T KUNG PHONE NO : 978-646-1440
22 CHERRY HILL DR. SE DECISION MADE: 13-DEC-07
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
ACCELLENT INC. 510(k) NO: K072354(TRADITIONAL)
ATTN: KARL STEINECK PHONE NO : 303-432-4939
100 FORDHAM ROAD SE DECISION MADE: 07-DEC-07
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHOLESTRAK HDL CHOLESTEROL HOME TEST
ACCUTECH, LLC. 510(k) NO: K072836(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE ROAD SE DECISION MADE: 27-DEC-07
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: STERRAD 100NX TEST PACK
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K071537(TRADITIONAL)
ATTN: REUBEN LAWSON PHONE NO : 949-789-8545
33 TECHNOLOGY DR. SE DECISION MADE: 18-DEC-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R-PORT II LAPAROSCOPIC ACCESS DEVICE
ADVANCED SURGICAL CONCEPTS 510(k) NO: K073170(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 03-DEC-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOGON
AGFA HEALTHCARE CORPORATION 510(k) NO: K073271(TRADITIONAL)
ATTN: TOM HOLBROOK PHONE NO : 519-746-6210
10 SOUTH ACADEMY ST. SE DECISION MADE: 05-DEC-07
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PLASMAIR, MODEL T2006
AIRINSPACE B.V. 510(k) NO: K070722(TRADITIONAL)
ATTN: WADE TETSUKA PHONE NO : 703-717-3339
43795 LEE MILL SQUARE SE DECISION MADE: 14-DEC-07
LEESBURG, VA 20176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALCON MULTI-PURPOSE SOLUTION
ALCON, INC. 510(k) NO: K071236(TRADITIONAL)
ATTN: KIM B KRACKE PHONE NO : 817-551-8338
6201 SOUTH FREEWAY SE DECISION MADE: 12-DEC-07
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURONAV SYSTEM AND NEURONAV DRIVE
ALPHA OMEGA LTD. 510(k) NO: K071697(TRADITIONAL)
ATTN: BAHEEJ DANIAL PHONE NO : 972 465 63327
HA'AVODA ST., P.O. BOX 810 SE DECISION MADE: 03-DEC-07
NAZARETH ILLIT, ISRAEL 17105 510(k) STATEMENT
DEVICE: LIFE+CEL BATTERY
AMCO INTERNATIONAL MANUFACTURING &510(k) NO: K071164(TRADITIONAL)
ATTN: ALEX HENDERSON PHONE NO : 303-646-3583
377 ZANE COURT SE DECISION MADE: 07-DEC-07
HILLSIDE VILLAGE 510(k) SUMMARY AVAILABLE FROM FDA
ELIZABETH, CO 80107
DEVICE: VALEO VBR
AMEDICA CORP. 510(k) NO: K073125(SPECIAL)
ATTN: ADAM HERDER PHONE NO : 202-552-5800
1331 H ST. NW, 12TH FLOOR SE DECISION MADE: 05-DEC-07
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROSOL SYSTEM
AMICI, INC. 510(k) NO: K063716(TRADITIONAL)
ATTN: MICHAEL BONO PHONE NO : 610-948-7100
518 VINCENT ST. SE DECISION MADE: 28-DEC-07
SPRING CITY, PA 19475 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSURE BLADDER IRRIGATION SET
AMSINO INTL., INC. 510(k) NO: K070873(TRADITIONAL)
ATTN: YI CHEN PHONE NO : 909-626-5888
855 TOWNE CENTER DR. SE DECISION MADE: 19-DEC-07
POMONA, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUS
ANGIODYNAMICS, INC. 510(k) NO: K072375(TRADITIONAL)
ATTN: BRIAN KUNST PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 13-DEC-07
QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC P
ANSELL HEALTHCARE PRODUCTS, LLC 510(k) NO: K071746(TRADITIONAL)
ATTN: CYNTHIA A INGRAM PHONE NO : 334-615-2563
1635 INDUSTRIAL ROAD SE DECISION MADE: 13-DEC-07
DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANSCOPE XT SYSTEM
APERIO TECHNOLOGIES 510(k) NO: K071671(TRADITIONAL)
ATTN: PERRY JOHNSTON PHONE NO : 760-539-1142
1430 VANTAGE COURT, SUITE 106 SE DECISION MADE: 28-DEC-07
VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICE-SENSE
ARBEL MEDICAL LTD. 510(k) NO: K072883(TRADITIONAL)
ATTN: ZVI LADIN PHONE NO : 781-407-0900
990 WASHINGTON ST. SE DECISION MADE: 10-DEC-07
DEDHAM, MA 02026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARC SURGICAL BIOTRAK PIN SYSTEM
ARC SURGICAL LLC. 510(k) NO: K071616(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-645-9300
21300 NW JACOBSON RD. SE DECISION MADE: 19-DEC-07
HILLSBORO, OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB
AVITA CORPORATION 510(k) NO: K072137(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340
2904 N. BOLDT DR. SE DECISION MADE: 07-DEC-07
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO 5MP, MODEL MDNG-5121
BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K073205(SPECIAL)
ATTN: NEIL PHILLIPS PHONE NO : 32 56 233211
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 19-DEC-07
KORTRIJK, BELGIUM B-8500 510(k) STATEMENT
DEVICE: ADVIA CHEMISTRY TOTAL BILIRUBIN_2
BAYER HEALTHCARE, LLC 510(k) NO: K063845(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443
511 BENEDICT AVE. SE DECISION MADE: 07-DEC-07
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-
BAYLIS MEDICAL CO., INC. 510(k) NO: K072478(SPECIAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875
2645 MATHESON BLVD. E SE DECISION MADE: 19-DEC-07
MISSISSAUGA, ONTARIO, CANADA L4W 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD GENEOHM STAPHSR ASSAY
BD DIAGNOSTICS (GENEOHM SCIENCES C510(k) NO: K071026(TRADITIONAL)
ATTN: RAYMOND BOULE PHONE NO : 858-334-6536
6146 NANCY RIDGE DRIVE SE DECISION MADE: 20-DEC-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPLATE
BIO PROTECH, INC. 510(k) NO: K073360(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
1676 VILLAGE GREEN SUITE A SE DECISION MADE: 19-DEC-07
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYSTEM-ARMS, MODEL 390,E60
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K072553(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 917 74300
PARKMORE BUSINESS PARK WEST SE DECISION MADE: 14-DEC-07
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOS
BIO-RAD, DIAGNOSTICS GRP. 510(k) NO: K072721(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 11-DEC-07
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
BIO-RAD, DIAGNOSTICS GRP. 510(k) NO: K072835(TRADITIONAL)
ATTN: SUZANNE PARSONS PHONE NO : 949-598-1467
9500 JERONIMO RD. SE DECISION MADE: 11-DEC-07
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE,
BIOARTIFICIAL GEL TECHNOLOGIES (BA510(k) NO: K072068(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 21-DEC-07
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
BIOKIT S.A. 510(k) NO: K072078(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 349 386 09000
CAN MALE S/N SE DECISION MADE: 19-DEC-07
LLICA D'AMUNT 510(k) SUMMARY AVAILABLE FROM FDA
BARCELONA, SPAIN 08186
DEVICE: MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K070458(TRADITIONAL)
ATTN: COURIVAUD CHRISTELLE PHONE NO : 331 646 21012
ACTIPOLE 25 SE DECISION MADE: 21-DEC-07
4-6 BLD DE BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA
MARNE LA VALLEE CEDEX 2, FRANCE 77435
DEVICE: MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K071210(TRADITIONAL)
ATTN: COURIVAUD CHRISTELLE PHONE NO : 33 164 621012
ACTIPOLE 25 SE DECISION MADE: 19-DEC-07
4-6 BLD DE BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA
MARNE LA VALLEE CEDEX 2, FRANCE 77435
DEVICE: VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
BIOMERIEUX, INC. 510(k) NO: K063243(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474
595 ANGLUM DR. SE DECISION MADE: 14-DEC-07
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
BIOMERIEUX, INC. 510(k) NO: K072138(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474
595 ANGLUM RD. SE DECISION MADE: 21-DEC-07
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM NEGATIVE PIPERACILLIN
BIOMERIEUX, INC. 510(k) NO: K073083(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 10-DEC-07
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
BIOMET 3I, INC. 510(k) NO: K072642(TRADITIONAL)
ATTN: DIANA TAYLOR PHONE NO : 561-776-6857
4555 RIVERSIDE DR. SE DECISION MADE: 20-DEC-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPREHENSIVE RS SHOULDER SYSTEM
BIOMET MANUFACTURING CORP. 510(k) NO: K072804(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 12-DEC-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPA
BIOMET, INC. 510(k) NO: K072330(TRADITIONAL)
ATTN: PAULA DEMING PHONE NO : 574-372-3917
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 06-DEC-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APL MEDICAL SYSTEM
BIOS S.R.L. 510(k) NO: K072344(TRADITIONAL)
ATTN: ALDO CASALINO PHONE NO : 390 227 304275
VIA GUIDO ROSSA, 10/12 SE DECISION MADE: 03-DEC-07
VIMODRONE (MILAN), ITALY I-20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
BIOSITE INCORPORATED 510(k) NO: K072892(TRADITIONAL)
ATTN: FIL V BUENVIAJE PHONE NO : 858-805-2722
9975 SUMMERS RIDGE RD SE DECISION MADE: 07-DEC-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASSEO 18
BIOTRONIK, INC. 510(k) NO: K072765(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN ROAD SE DECISION MADE: 12-DEC-07
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
BIOTRONIK, INC. 510(k) NO: K073230(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN ROAD SE DECISION MADE: 20-DEC-07
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISICO IMPRESSION SILICONES & ALGINATES
BISICO GMBH & CO KG 510(k) NO: K072577(TRADITIONAL)
ATTN: DAGMAR MAESER PHONE NO : 31 20 4289591
AMSTEL 320-I SE DECISION MADE: 05-DEC-07
AMSTERDAM, NETHERLANDS 33611 510(k) STATEMENT
DEVICE: ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP
BLUE CROSS BIO-MEDICAL CO., LTD. 510(k) NO: K071930(TRADITIONAL)
ATTN: HILDA HONG YANG PHONE NO : 010 697 56047
BEIQIJA INDUSTRY ZONE SE DECISION MADE: 18-DEC-07
CHANGPING DISTRICT 510(k) STATEMENT
BEIJING, CHINA 102209
DEVICE: THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K072476(TRADITIONAL)
ATTN: VIRGINIA CARR PHONE NO : 508-683-4454
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 14-DEC-07
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M ESPE LAVA CHAIRSIDE ORAL SCANNER
BRONTES TECHNOLOGIES 510(k) NO: K073199(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 21-DEC-07
SOUTHWEST RANCHES, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T
BRYMILL CORP. 510(k) NO: K072453(TRADITIONAL)
ATTN: STEPHEN WILLIAMS PHONE NO : 860-875-2460
105 WINDERMERE AVE., BLDG. 2 SE DECISION MADE: 03-DEC-07
WINDERMERE INDUSTRIAL PARK 510(k) STATEMENT
ELLINGTON, CT 06029
DEVICE: BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SI
C.R. BARD, INC. 510(k) NO: K070558(TRADITIONAL)
ATTN: SKIP RIMER PHONE NO : 770-784-6160
8195 INDUSTRIAL BLVD. SE DECISION MADE: 07-DEC-07
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C.
C.R. BARD, INC. 510(k) NO: K070582(TRADITIONAL)
ATTN: SKIP RIMER PHONE NO : 770-784-6160
8195 INDUSTRIAL BLVD. SE DECISION MADE: 07-DEC-07
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
C.R. BARD, INC. 510(k) NO: K073423(SPECIAL)
ATTN: SUSAN D SCOTT PHONE NO : 801-595-0700
605 N 5600 W SE DECISION MADE: 19-DEC-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINCH KNOTLESS FIXATION IMPLANT SYSTEM
C2M MEDICAL, INC. 510(k) NO: K073226(SPECIAL)
ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-582-5827
3463 MAGIC DRIVE SE DECISION MADE: 07-DEC-07
SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78229
DEVICE: CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K071995(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484019
2 PEKERIS ST. P.O. BOX 527 SE DECISION MADE: 18-DEC-07
REHOVOT, ISRAEL 76101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150
CARDICA, INC. 510(k) NO: K073123(SPECIAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-331-7153
900 SAGINAW DR. SE DECISION MADE: 06-DEC-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-C
CARDICA, INC. 510(k) NO: K073304(SPECIAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-331-7153
900 SAGINAW DR. SE DECISION MADE: 20-DEC-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARIS SYSTEM WITH MMS, MODEL 8XXX
CARDINAL HEALTH 303, INC. 510(k) NO: K072105(SPECIAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIR. SE DECISION MADE: 28-DEC-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSITE STOPCOCK
CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K071400(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIRCLE SE DECISION MADE: 14-DEC-07
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODE
CARDIONET, INC 510(k) NO: K072558(ABBREVIATED)
ATTN: JACK GAIKWAD PHONE NO : 714-713-9011
1010 2ND AVE., SUITE 700 SE DECISION MADE: 05-DEC-07
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHASE MR SYSTEM
CHASE MEDICAL, LP 510(k) NO: K072473(TRADITIONAL)
ATTN: DAVID M HERNON PHONE NO : 972-783-0644
1876 FIRMAN DR. SE DECISION MADE: 10-DEC-07
RICHARDSON, TX 75081 510(k) STATEMENT
DEVICE: ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE W
CINCINNATI SUB-ZERO PRODUCTS, INC 510(k) NO: K072621(TRADITIONAL)
ATTN: FATMA ALI PHONE NO : 513-719-3305
12011 MOSTELLER ROAD SE DECISION MADE: 13-DEC-07
CINCINNATI, OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATO
CLINICAL DATA, INC. 510(k) NO: K071706(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 WEST LAMBERT ROAD SE DECISION MADE: 20-DEC-07
BREA, CA 92821-2944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060,
CONCENTRIC MEDICAL, INC. 510(k) NO: K072796(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650-810-1707
301 E. EVELYN AVE. SE DECISION MADE: 18-DEC-07
MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONEPORT SURGICAL TROCAR SYSTEM
CONMED CORPORATION 510(k) NO: K073009(TRADITIONAL)
ATTN: BRIAN KILLORAN PHONE NO : 315-624-3219
525 FRENCH RD. SE DECISION MADE: 07-DEC-07
UTICA, NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
COOK, INC. 510(k) NO: K072625(TRADITIONAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 13-DEC-07
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE 18LP PTA DILATATION CATHETER
COOK, INC. 510(k) NO: K073378(SPECIAL)
ATTN: NATHAN SIMON PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 28-DEC-07
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
CREASPINE SAS 510(k) NO: K072537(TRADITIONAL)
ATTN: CYNTHIA J.M NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 18-DEC-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)
CRS MEDICAL DIAGNOSTICS INC. 510(k) NO: K072518(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 20-DEC-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXCATH STEERABLE SHEATH & DILATOR
CRYOCATH TECHNOLOGIES, INC. 510(k) NO: K070357(TRADITIONAL)
ATTN: FRED MILDER PHONE NO : 505-955-8936
10 B TANO ROAD SE DECISION MADE: 28-DEC-07
SANTA FE, NM 87506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM
CSA MEDICAL, INC. 510(k) NO: K072651(ABBREVIATED)
ATTN: JENNIFER CARTLEDGE PHONE NO : 443-921-8053
1101 E. 33RD STREET SE DECISION MADE: 07-DEC-07
THIRD FLOOR - #E305 510(k) SUMMARY AVAILABLE FROM FDA
BALTIMORE, MD 21218
DEVICE: ISSYS LP SPINAL FIXATION SYSTEM
CUSTOM SPINE, INC. 510(k) NO: K072866(TRADITIONAL)
ATTN: SAAD ATTIYAH PHONE NO : 973-808-0019
1140 PARSIPPANY BLVD. SE DECISION MADE: 13-DEC-07
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
PARSIPPANY, NJ 07054
DEVICE: CYNOSURE YAG FAMILY LASER
CYNOSURE, INC. 510(k) NO: K072484(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 27-DEC-07
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTLIPO LASER
CYNOSURE, INC. 510(k) NO: K073394(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 12-DEC-07
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTORI AFT SYSTEM
CYTORI THERAPEUTICS, INC. 510(k) NO: K072587(TRADITIONAL)
ATTN: KENNETH KLEINHENZ PHONE NO : 858-458-0900
3020 CALLAN ROAD SE DECISION MADE: 10-DEC-07
SAN DIEGO, CA 92121-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
DADE BEHRING, INC. 510(k) NO: K072717(TRADITIONAL)
ATTN: HELEN M LEE PHONE NO : 302-631-8706
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 12-DEC-07
P.O. BOX 6101; MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
DADE BEHRING, INC. 510(k) NO: K072965(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 21-DEC-07
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTIN DESENSITIZER AGENT
DENTSPLY INTL., INC. 510(k) NO: K073117(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CENTER SE DECISION MADE: 19-DEC-07
221 W PHILADELPHIA ST. STE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DEPUY LPS DISTAL FEMORAL COMPONENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K063686(TRADITIONAL)
ATTN: REBECCA LENNARD PHONE NO : 574-372-5023
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 20-DEC-07
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K072832(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-328-3851
700 ORTHOPAEDIC DR. SE DECISION MADE: 14-DEC-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K073126(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852
325 PARAMOUNT DR. SE DECISION MADE: 06-DEC-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL
DIADEXUS, INC. 510(k) NO: K072599(TRADITIONAL)
ATTN: ROBERT WOLFERT PH.D PHONE NO : 650-246-6430
343 OYSTER POINT BLVD. SE DECISION MADE: 20-DEC-07
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K071375(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 21-DEC-07
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K071679(TRADITIONAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
11 HAHOSHLIM ST. SE DECISION MADE: 17-DEC-07
HERZLIYA, ISRAEL 46724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASHLITE REBEL*
DISCUS DENTAL, INC. 510(k) NO: K073518(TRADITIONAL)
ATTN: VIVIAN LAI PHONE NO : 310-845-8347
8550 HIGUERA ST. SE DECISION MADE: 20-DEC-07
CULVER CITY, CA 90232-2522 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: D3 HEMATOLOGY ANALYZER, MODEL D3
DREW SCIENTIFIC, INC. 510(k) NO: K071562(TRADITIONAL)
ATTN: ROGER BOURREE PHONE NO : 214-210-4914
4230 SHILLING WAY SE DECISION MADE: 11-DEC-07
DALLAS, TX 75237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS PIEZON MASTER SURGERY
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K072146(TRADITIONAL)
ATTN: SUSAN BONAPACE PHONE NO : 508-316-7110
49 PLAIN ST SE DECISION MADE: 18-DEC-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE II
EDAN INSTRUMENTS, INC. 510(k) NO: K073221(SPECIAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200
1 ODELL PLAZA SE DECISION MADE: 28-DEC-07
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR LCD MONITOR, FLEXSCAN MX300W
EIZO NANAO CORPORATION 510(k) NO: K073340(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 19-DEC-07
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K072159(TRADITIONAL)
ATTN: ANDREA TOZZI PHONE NO : 055 882 6807
17 VIA BALDANZESE SE DECISION MADE: 27-DEC-07
CALENZANO, ITALY 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
ENCORE MEDICAL, L.P. 510(k) NO: K072154(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 14-DEC-07
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
ENDIUS, INC. 510(k) NO: K072840(TRADITIONAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 07-DEC-07
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERAPEUTIC MASSAGE COMPANION
ENDURANCE THERAPEUTICS 510(k) NO: K060846(TRADITIONAL)
ATTN: BRAD BREZDEN PHONE NO : 877 274 4962
122B - FIRST STREET NE SE DECISION MADE: 03-DEC-07
DAUPHIN, MANITOBA, CANADA R7N 1B5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STASILON FR
ENTEGRION, INC. 510(k) NO: K072890(TRADITIONAL)
ATTN: E.S. ESKRIDGE, JR. PHONE NO : 919-536-1500
79 TW ALEXANDER DRIVE SUITE 20 SE DECISION MADE: 10-DEC-07
4401 RESEARCH COMMONS 510(k) SUMMARY AVAILABLE FROM FDA
RESEARCH TRIANGLE PARK, NC 27709
DEVICE: TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
ENVISIONEERING, LLC. 510(k) NO: K073399(SPECIAL)
ATTN: DAVID KENNEDY PHONE NO : 314-429-7367
1982 INNERBELT BUSINESS CTR DR SE DECISION MADE: 21-DEC-07
ST. LOUIS, MO 63114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND
EPS BIO TECHNOLOGY CORP. 510(k) NO: K070053(TRADITIONAL)
ATTN: Y.C. LEI PHONE NO : 886 3 5752522
2 F,NO.49-2, LANE 2, SEC. 2, SE DECISION MADE: 03-DEC-07
GUANG FU ROAD 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU CITY, CHINA (TAIWAN) 300
DEVICE: THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE
ESM TECHNOLOGIES, LLC. 510(k) NO: K072231(TRADITIONAL)
ATTN: CLIFF TRIBUS PHONE NO : 608-467-8324
403 FARWELL DR. SE DECISION MADE: 26-DEC-07
MADISON, WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDTA PLUS
ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K072555(TRADITIONAL)
ATTN: BRIAN RASIMICK PHONE NO : 201-487-9090
89 LEUNING ST. SE DECISION MADE: 13-DEC-07
SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
SOUTH HACKENSACK, NJ 07606
DEVICE: BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPT
ETAC SVERIGE AB 510(k) NO: K072475(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 512-327-9997
1705 CAPITAL OF TEXAS HIGHWAY SE DECISION MADE: 21-DEC-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: EUROIMMUN ANTI-CCP ELISA
EUROIMMUN US LLC 510(k) NO: K070789(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-402-6101
429 ROCKAWAY VALLEY RD. SE DECISION MADE: 31-DEC-07
UNIT 1200 510(k) STATEMENT
BOONTON, NJ 07005
DEVICE: HYALOMATRIX PA
FIDIA ADVANCED BIOPOLYMERS SRL 510(k) NO: K073251(TRADITIONAL)
ATTN: SHARON A SEGAL PHONE NO : 202-739-5427
1111 PENNSYLVANIA AVE NW SE DECISION MADE: 14-DEC-07
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE CROSSER SYSTEM
FLOWCARDIA, INC. 510(k) NO: K072776(TRADITIONAL)
ATTN: DUSTIN MICHAELS PHONE NO : 408-617-0352
745 N. PASTORIA AVE. SE DECISION MADE: 07-DEC-07
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FD EMS, MODEL # D-FJ30E
FUJI DYNAMICS LIMITED 510(k) NO: K063642(TRADITIONAL)
ATTN: IRENE CHEUNG PHONE NO : 852 278 64218
01-03, 23/F, LAWS COMMERCIAL SE DECISION MADE: 13-DEC-07
PLAZA, CHEUNG SHAWAN RD. 510(k) SUMMARY AVAILABLE FROM FDA
KOWLEON, HONG KONG, CHINA
DEVICE: GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M10507
GE HEALTHCARE 510(k) NO: K062580(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 21-DEC-07
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 250CX SERIES MATERNAL/FETAL MONITOR
GE HEALTHCARE 510(k) NO: K072976(SPECIAL)
ATTN: AGATA SMIEJA PHONE NO : 410-888-5218
8880 GORMAN RD SE DECISION MADE: 20-DEC-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K073408(SPECIAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 414-721-2272
9900 INNOVATION DR. SE DECISION MADE: 19-DEC-07
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ P6
GENERAL ELECTRIC CO. 510(k) NO: K073297(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 18-DEC-07
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF4 IGG
GENETIC TESTING INSTITUTE 510(k) NO: K071781(TRADITIONAL)
ATTN: SUZETTE C CHANCE PHONE NO : 262-754-1034
20925 CROSSROADS CIRCLE SE DECISION MADE: 19-DEC-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53186-4054
DEVICE: BEACON STABILIZATION SYSTEM
GLOBUS MEDICAL INC. 510(k) NO: K073172(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 13-DEC-07
AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROFUSE BONE VOID FILLER
GLOBUS MEDICAL, INC. 510(k) NO: K071187(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 20-DEC-07
VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
AUDUBON, PA 19403
DEVICE: DM-EMG
GVP ELETTRONICA SRL 510(k) NO: K072513(TRADITIONAL)
ATTN: JOHN ROMANO PHONE NO : 215-493-0352
6 DURHAM BOAT DRIVE SE DECISION MADE: 07-DEC-07
WASHINGTON CROSSING, PA 18977 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SY
GYRUS ACMI, INC. 510(k) NO: K072594(TRADITIONAL)
ATTN: GRAHAM A BAILLIE PHONE NO : 508-804-2738
136 TURNPIKE RD. SE DECISION MADE: 13-DEC-07
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REHASTIM & REHAMOVE
HASOMED GMBH 510(k) NO: K073237(TRADITIONAL)
ATTN: MATTHIAS WEBER PHONE NO : 493 916 107653
PAUL-ECKE-STRASSE 1 SE DECISION MADE: 27-DEC-07
MAGDEBURG, GERMANY 39114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K073044(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO.58, FU-CHIUN ST. SE DECISION MADE: 07-DEC-07
HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 10
HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K071150(TRADITIONAL)
ATTN: DAGMAR MAESER PHONE NO : 312 042 89591
AMSTEL 320-1 SE DECISION MADE: 12-DEC-07
AMSTERDAM, NETHERLANDS D-72144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMAWAY SEAT
HEMAWAY LLC 510(k) NO: K072690(TRADITIONAL)
ATTN: ARCHIE ROSENBLUM PHONE NO : 973-236-1110
2207 CONCORD PIKE, SUITE 528 SE DECISION MADE: 07-DEC-07
WILMINGTON, DE 19803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
HITACHI, LTD., POWER SYSTEMS GROUP510(k) NO: K073059(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 10-DEC-07
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
IDAHO TECHNOLOGY, INC. 510(k) NO: K072547(TRADITIONAL)
ATTN: BETH LINGENFELTER PHONE NO : 801-736-6354
390 WAKARA WAY SE DECISION MADE: 19-DEC-07
SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
IDAHO TECHNOLOGY, INC. 510(k) NO: K072631(TRADITIONAL)
ATTN: BETH LINGENFELTER PHONE NO : 801-736-6354
390 WAKARA WAY SE DECISION MADE: 20-DEC-07
SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGACY DENTAL IMPLANTS
IMPLANT DIRECT LLC 510(k) NO: K073033(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317
27030 MALIBU HILLS RD. SE DECISION MADE: 10-DEC-07
CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCREWPLUS DENTAL IMPLANTS (HA)
IMPLANT DIRECT LLC 510(k) NO: K073049(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317
27030 MALIBU HILLS RD. SE DECISION MADE: 13-DEC-07
CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
IMTEC CORP. 510(k) NO: K072660(TRADITIONAL)
ATTN: J. BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 12-DEC-07
ARDMORE, OK 73401 510(k) STATEMENT
DEVICE: HEMOSIL FIBRINOGEN-C
INSTRUMENTATION LABORATORY CO. 510(k) NO: K073367(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 27-DEC-07
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SY
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K072929(SPECIAL)
ATTN: DARLENE M WELSH PHONE NO : 609-936-2307
311 ENTERPRISE DR. SE DECISION MADE: 07-DEC-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE INVACARE FLYER, MODEL IPC 100
INVACARE CORP. 510(k) NO: K071928(TRADITIONAL)
ATTN: CARROLL MARTIN PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 12-DEC-07
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: ION MEDICAL BIPOLAR COAGULATION PEN
ION MEDICAL, LLC 510(k) NO: K072911(TRADITIONAL)
ATTN: KEITH HURON PHONE NO : 904-645-7303
6900 PHILIPS HIGHWAY SE DECISION MADE: 13-DEC-07
SUITE 41 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32216
DEVICE: IRISPEC,CA/CB/CC
IRIS DIAGNOSTICS 510(k) NO: K072640(ABBREVIATED)
ATTN: GERALD HADDOCK PHONE NO : 818-709-1244
9172 ETON AVE. SE DECISION MADE: 21-DEC-07
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-
JG MEDICAL PRODUCTS LLC 510(k) NO: K070021(TRADITIONAL)
ATTN: WILLAIM STERN PHONE NO : 914-376-5200
1 ODELL PLAZA SE DECISION MADE: 07-DEC-07
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STORZ MODULITH LITHOTRIPTER SLX-F2-F180
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K072788(TRADITIONAL)
ATTN: CRYSTAL DIZOL PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 26-DEC-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENSEY NASH MACROPORE SHIELD
KENSEY NASH CORP. 510(k) NO: K071695(TRADITIONAL)
ATTN: CINDY VARUGHESE PHONE NO : 484-713-2174
735 PENNSYLVANIA DRIVE SE DECISION MADE: 31-DEC-07
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STANDOUT 2
KERR CORP. 510(k) NO: K072622(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602
1717 W. COLLINS AVENUE SE DECISION MADE: 04-DEC-07
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS MARTIN XTERNAL FIXATOR
KLS MARTIN L.P. 510(k) NO: K072764(TRADITIONAL)
ATTN: TOM FAUCETT PHONE NO : 800-625-1557
11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 20-DEC-07
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: PATIENT CONTOURED MESH-PEEK (PCM-P)
KLS-MARTIN L.P. 510(k) NO: K072707(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 19-DEC-07
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: POLYBONE
KYUNGWON MEDICAL CO., LTD. 510(k) NO: K070012(TRADITIONAL)
ATTN: JOO YEON LEE PHONE NO : 562-404-8466
13340E FIRESTONE BLVD. SE DECISION MADE: 27-DEC-07
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
LANX, LLC 510(k) NO: K071905(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 202-675-4611
1835 MARKET STREET, 28TH FLOOR SE DECISION MADE: 28-DEC-07
PHILADELPHIA, PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980
LUMEN DEVELOPMENT AND MANUFACTURIN510(k) NO: K072995(TRADITIONAL)
ATTN: CALVIN D OSTLER PHONE NO : 801-561-8998
532 WEST 8360 SOUTH SE DECISION MADE: 18-DEC-07
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM
LUTRONIC CORPORATION 510(k) NO: K073436(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 28-DEC-07
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
MAKO SURGICAL CORP. 510(k) NO: K073248(SPECIAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2555 DAVIE RD., SUITE 110 SE DECISION MADE: 12-DEC-07
FT. LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
MCNEIL-PPC, INC. 510(k) NO: K072360(TRADITIONAL)
ATTN: NADER FOTOUHU, PH.D. PHONE NO : 908-904-3730
199 GRANDVIEW ROAD SE DECISION MADE: 12-DEC-07
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AN
MED-LECTRIC CORPORATION 510(k) NO: K071878(TRADITIONAL)
ATTN: M. LEE GUNTER PHONE NO : 281-334-5166
1909 LAWRENCE ROAD SE DECISION MADE: 07-DEC-07
# 100 510(k) SUMMARY AVAILABLE FROM FDA
KEMAH, TX 77565
DEVICE: SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301
MEDEVICE, INC. 510(k) NO: K072550(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 07-DEC-07
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPIX SPACER
MEDICREA TECHNOLOGIES 510(k) NO: K072226(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 10-DEC-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K072511(ABBREVIATED)
ATTN: ARI Y SOBEL PHONE NO : 610-594-3446
101 GORDON DRIVE SE DECISION MADE: 13-DEC-07
LIONVILLE, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIAL2BAG
MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K072759(ABBREVIATED)
ATTN: ARI Y SOBEL PHONE NO : 610-594-3446
101 GORDON DRIVE SE DECISION MADE: 13-DEC-07
LIONVILLE, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
MEDRAD, INC. 510(k) NO: K072886(TRADITIONAL)
ATTN: LISA M CASAVANT PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 21-DEC-07
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT
MEDTRADE PRODUCTS LTD. 510(k) NO: K072328(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019
ELECTRA HOUSE SE DECISION MADE: 21-DEC-07
CREWE BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL
DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K071942(TRADITIONAL)
ATTN: MICHELLE WILLIS PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 11-DEC-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
MEDWAVES INCORPORATED 510(k) NO: K070356(TRADITIONAL)
ATTN: TED ORMSBY PHONE NO : 858-946-0015
16760 WEST BERNARDO DRIVE SE DECISION MADE: 18-DEC-07
SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-QUEST SYSTEM
MEDX, INC. 510(k) NO: K073456(TRADITIONAL)
ATTN: MICHAEL HANUSHEWSKY PHONE NO : 847-463-2020
3456 NORTH RIDGE AVE., #100 SE DECISION MADE: 20-DEC-07
ARLINGTON HEIGHTS, IL 60004 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEMOMETAL BONE ANCHORS
MEMOMETAL TECHNOLOGIES 510(k) NO: K071941(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 332 990 55969
RUE BLAISE PASCAL SE DECISION MADE: 04-DEC-07
CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA
BRUZ, FRANCE F35170
DEVICE: MERILAS 532A
MERIDIAN AG 510(k) NO: K072823(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 14-DEC-07
LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K072552(TRADITIONAL)
ATTN: WILLIAM D JORDAN PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 14-DEC-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-
MICROLIFE CORP. 510(k) NO: K073397(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD. SE DECISION MADE: 20-DEC-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP
MICROLIFE CORP. 510(k) NO: K073398(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD. SE DECISION MADE: 20-DEC-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MILESMAN PREMIUM
MILESMAN S.L. 510(k) NO: K073300(TRADITIONAL)
ATTN: NATALYA VALERIO PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 04-DEC-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: SPIROBANK G
MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K072979(SPECIAL)
ATTN: SIMON FOWLER PHONE NO : 39 062 2754777
VIA DEL MAGGIOLINO 125 SE DECISION MADE: 26-DEC-07
ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICAL DISPLAY, MD205MG
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K073448(TRADITIONAL)
ATTN: SHUICHI KINO PHONE NO : 814 658 52376
686-1 NISHIOI, OI-MACHI SE DECISION MADE: 20-DEC-07
ASHIGARAKAMI-GUN, KANAGAWA, JAPAN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PURITAN BENNETT LEGENDAIR XL2
NELLCOR PURITAN BENNETT 510(k) NO: K070899(TRADITIONAL)
ATTN: JAMES BONDS PHONE NO : 925-463-4371
4280 HACIENDA DR. SE DECISION MADE: 13-DEC-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL SHOT ALPHA
NEMOTO KYORINDO CO., LTD. 510(k) NO: K071691(SPECIAL)
ATTN: MICHAEL HIEDA PHONE NO : 949-632-6183
24992 DEL MONTE ST. SE DECISION MADE: 19-DEC-07
LAGUNA HILLS, CA 92653-5617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOMED URINARY CATHETER
NEOMED, INC. 510(k) NO: K072997(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678-428-6978
717 LAKEGLEN DR. SE DECISION MADE: 19-DEC-07
SUWANEE, GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMIGO INSULIN PUMP
NIPRO DIABETES SYSTEMS, INC. 510(k) NO: K071613(TRADITIONAL)
ATTN: HARRY RUSSELL PHONE NO : 954-435-5665
3361 ENTERPRISE PKWY. SE DECISION MADE: 14-DEC-07
MIRAMAR, FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
NOBEL BIOCARE AB 510(k) NO: K070857(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 28-DEC-07
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELACTIVE MULTI UNIT ABUTMENT
NOBEL BIOCARE AB 510(k) NO: K072570(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PKWY. SE DECISION MADE: 28-DEC-07
YORBA LINDA, CA 92887 510(k) STATEMENT
DEVICE: NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
NOBEL BIOCARE AB 510(k) NO: K072980(SPECIAL)
ATTN: KAM LEUNG PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 20-DEC-07
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
NUCLETRON CORPORATION 510(k) NO: K073107(SPECIAL)
ATTN: LISA] DIMMICK PHONE NO : 443-545-2196
8671 ROBERT FULTON DR. SE DECISION MADE: 07-DEC-07
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUAL DOSE 1.0
NUCLETRON CORPORATION 510(k) NO: K073273(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 443-545-2196
8671 ROBERT FULTON DR. SE DECISION MADE: 11-DEC-07
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIFE4C
NUMEDIS, INC. 510(k) NO: K063304(TRADITIONAL)
ATTN: MARY E FREDDO PHONE NO : 603-661-3716
188 BUMSTEAD RD. SE DECISION MADE: 21-DEC-07
MONSON, MA 01057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE COROENT SYSTEM
NUVASIVE, INC. 510(k) NO: K071795(ABBREVIATED)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE COURT SE DECISION MADE: 04-DEC-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
OLSEN MEDICAL 510(k) NO: K072937(TRADITIONAL)
ATTN: JOHN P WATERS PHONE NO : 502-772-4272
3001 WEST KENTUCKY ST. SE DECISION MADE: 28-DEC-07
LOUISVILLE, KY 40211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
OMNIGUIDE, INC. 510(k) NO: K073409(TRADITIONAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617-551-8404
ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 14-DEC-07
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139 THIRD PARTY REVIEW
DEVICE: SAPPHIRE CERAMIC BRACKET
ORTHO TECHNOLOGY, INC 510(k) NO: K073045(TRADITIONAL)
ATTN: PAUL WILLIAMS PHONE NO : 813-991-5896
17401 COMMERCE PARK BLVD. SE DECISION MADE: 18-DEC-07
TAMPA, FL 33647 510(k) STATEMENT
DEVICE: VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K073157(SPECIAL)
ATTN: MARLENE HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 07-DEC-07
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
OSTEOSYMBIONICS, LLC 510(k) NO: K072601(TRADITIONAL)
ATTN: CYNTHIA M BROGAN PHONE NO : 216-881-8500
1768 EAST 25TH STREET SE DECISION MADE: 10-DEC-07
CLEVELAND, OH 44114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K072670(SPECIAL)
ATTN: JAMES MCINTIRE PHONE NO : 804-639-7274
2943 OAKLAKE BLVD. SE DECISION MADE: 13-DEC-07
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LINASYS
PATHFINDER THERAPEUTICS, INC. 510(k) NO: K071063(TRADITIONAL)
ATTN: JAMES D STEFANSIC PHONE NO : 615-783-0094
2969 ARMORY DRIVE SE DECISION MADE: 20-DEC-07
SUITE 100A 510(k) SUMMARY AVAILABLE FROM FDA
NASHVILLE, TN 37204
DEVICE: RM BOND, MODEL J032
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K072830(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 04-DEC-07
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: PENUMBRA SYSTEM
PENUMBRA, INC. 510(k) NO: K072718(TRADITIONAL)
ATTN: THERESA BRANDNER-ALLEN PHONE NO : 510-618-3223
2401 MERCED ST., SUITE 200 SE DECISION MADE: 28-DEC-07
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: T-PORT HP INFUSION PORT
PFM MEDICAL, INC 510(k) NO: K073210(SPECIAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760-758-8749
2605 TEMPLE HEIGHTS DRIVE SE DECISION MADE: 12-DEC-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
OCEANSIDE, CA 92056
DEVICE: ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODE
PHADIA US INC. 510(k) NO: K072393(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVE. SE DECISION MADE: 07-DEC-07
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST MODELS, 9308T AND 9308X
PHAMATECH INC. 510(k) NO: K070009(TRADITIONAL)
ATTN: CARL MONGIOVI PHONE NO : 858-643-5555
10151 BARNES CANYON RD SE DECISION MADE: 07-DEC-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; M
PHAMATECH INC. 510(k) NO: K070098(TRADITIONAL)
ATTN: CARL MONGIOVI PHONE NO : 858-643-5555
10151 BARNES CANYON RD SE DECISION MADE: 07-DEC-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)
PHASEIN AB 510(k) NO: K072813(TRADITIONAL)
ATTN: DAVID WEISSBURG PHONE NO : 608-770-0223
4213 WINNEQUAH DR. SE DECISION MADE: 28-DEC-07
MADISON, WI 53716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
PHILIPS MEDICAL SYSTEMS 510(k) NO: K071885(TRADITIONAL)
ATTN: PETER SCHIPELLITI PHONE NO : 978-687-1501
3000 MINUTEMAN RD. SE DECISION MADE: 20-DEC-07
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
PLAYTEX PRODUCTS, INC. 510(k) NO: K072376(TRADITIONAL)
ATTN: KEITH EDGETT PHONE NO : 302-678-6880
804 WALKER RD. SE DECISION MADE: 12-DEC-07
DOVER, DE 19904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPROTEIN REAGENT SET
POINTE SCIENTIFIC, INC. 510(k) NO: K070757(TRADITIONAL)
ATTN: RON JAMISON PHONE NO : 734-487-8310
5449 RESEARCH DRIVE SE DECISION MADE: 04-DEC-07
CANTON, MI 48188 510(k) STATEMENT
DEVICE: PVMED DDR 2520 DIGITAL IMAGING SYSTEM
PORTAVISION MEDICAL 510(k) NO: K072766(TRADITIONAL)
ATTN: IAN GORDEN PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY. SE DECISION MADE: 11-DEC-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746 THIRD PARTY REVIEW
DEVICE: IDRIVES, IDRIVEC, IDRIVEF
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K073001(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
2021 CABOT BLVD. SE DECISION MADE: 18-DEC-07
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K073148(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
2021 CABOT BLVD. SE DECISION MADE: 07-DEC-07
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL HIP SURGETICS NAVIGATION SYSTEM
PRAXIM SA 510(k) NO: K072267(TRADITIONAL)
ATTN: JIHANE ZEMMOURI PHONE NO : 003 347 6549503
LE GRAND SABLON SE DECISION MADE: 10-DEC-07
4 AVENUE DE L'OBIOU 510(k) SUMMARY AVAILABLE FROM FDA
LA TRONCHE, FRANCE 38700
DEVICE: THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT
PRESTIGE BRANDS, INC. 510(k) NO: K073220(SPECIAL)
ATTN: KAREN A COSTA-STRACHAN PHONE NO : 914-524-6842
90 N BROADWAY SE DECISION MADE: 19-DEC-07
IRVINGTON, NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINESSE SYSTEM
PRIMAEVA MEDICAL, INC. 510(k) NO: K072261(TRADITIONAL)
ATTN: SEVRINA CIUCCI PHONE NO : 408-316-4837
42840 CHRISTY STREET SE DECISION MADE: 26-DEC-07
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
FREMONT, CA 94538
DEVICE: DO-ALL DENTAL HANDPIECE LUBRICANT
PRODRIVE SYSTEMS, INC. 510(k) NO: K073353(TRADITIONAL)
ATTN: TIMOTHY F NASON PHONE NO : 866-747-8574
812 COMMERCE DR. SE DECISION MADE: 07-DEC-07
OGDENSBURG, NY 13669 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NON-IV ADAPTER FOR INFANT NG TUBE
PROMEDIC, INC. 510(k) NO: K072756(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT., #102 SE DECISION MADE: 19-DEC-07
BONITA SPRINGS, FL 34134-2015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXA
PROSURG, INC. 510(k) NO: K072528(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 28-DEC-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTPACK HCG IMMUNOASSAY
QUALIGEN, INC. 510(k) NO: K072264(TRADITIONAL)
ATTN: MICHAEL S POIRIER PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 06-DEC-07
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 308 DERMATOLOGICAL EXCIMER SYSTEM
QUANTEL MEDICAL, INC. 510(k) NO: K073066(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 26-DEC-07
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
R & D SYSTEMS, INC. 510(k) NO: K073178(TRADITIONAL)
ATTN: NANCY C RING PHONE NO : 612-656-4533
614 MCKINLEY PL., N.E. SE DECISION MADE: 27-DEC-07
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE MICRO
RESMED LTD. 510(k) NO: K072940(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 13-DEC-07
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K072450(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 760-918-7458
2271 COSMOS CT. SE DECISION MADE: 12-DEC-07
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFORMAX SE TOTAL FACE MASK
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K072588(TRADITIONAL)
ATTN: ZITA YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 18-DEC-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFORMAX TOTAL FACE MASK
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K072592(TRADITIONAL)
ATTN: ZITA YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 19-DEC-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
RESPIRONICS, INC. 510(k) NO: K072996(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 27-DEC-07
MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT SAFE SYRINGE
RETRACTABLE TECHNOLOGIES, INC. 510(k) NO: K072654(TRADITIONAL)
ATTN: RHONDA WELLS PHONE NO : 972-294-1010
511 LOBO LN. SE DECISION MADE: 14-DEC-07
LITTLE ELM, TX 75068-0009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
SAN SHIH ELECTRICAL ENTERPRISE CO.510(k) NO: K071093(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN STREET SE DECISION MADE: 06-DEC-07
HSIN CHU CITY, TAIWAN, CHINA (TAIW510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPASS
SCANDITRONIX WELLHOFER GMBH 510(k) NO: K072374(TRADITIONAL)
ATTN: MARTIN AROLD PHONE NO : 499 128 6070
BAHNOFSTRASSE 5 SE DECISION MADE: 07-DEC-07
SCHWARZENBRUCK, GERMANY 90592 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WI
SCICAN LTD. 510(k) NO: K072466(TRADITIONAL)
ATTN: TERESA BOYCE PHONE NO : 416 446 2783
1440 DON MILLS RD. SE DECISION MADE: 19-DEC-07
TORONTO, ONTARIO, CANADA M3B 3P9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SET PP
SDI LTD. 510(k) NO: K073043(TRADITIONAL)
ATTN: RAY CAHILL PHONE NO : 61 3 87277107
5-9 BRUNSDON ST. SE DECISION MADE: 14-DEC-07
BAYSWATER, VICTORIA, AUSTRALIA 315510(k) STATEMENT
DEVICE: MALIBU SPINAL SYSTEM
SEASPINE, INC. 510(k) NO: K072605(TRADITIONAL)
ATTN: ETHEL BERNAL PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 20-DEC-07
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPILLARYS URINE (PN 2012)
SEBIA, INC. 510(k) NO: K070486(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 770-446-3707
1705 CORPORATE DR. SE DECISION MADE: 21-DEC-07
SUITE 400 510(k) STATEMENT
NORCROSS, GA 30093
DEVICE: BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K073127(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 021 642 64467
SUITE 8D, NO.19, LANE 999 SE DECISION MADE: 20-DEC-07
ZHONGSHAN NO.2 ROAD(S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: SELF SEAL STERILIZATION POUCH
SHANGHAI JIANZHONG MEDICAL PACKAGI510(k) NO: K071886(TRADITIONAL)
ATTN: LONGFU SONG PHONE NO : 86 21 53079468
1558-1-2101 SOUTH XIZANG ROAD SE DECISION MADE: 27-DEC-07
SHANGHAI, CHINA 200011 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG PROSPEROUS PLASTIC CO510(k) NO: K073193(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
RM 1606 BLDG 1, JIANXIANG YUAN SE DECISION MADE: 20-DEC-07
NO 209 BEI SI HUAN ZHONG ROA 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 10083
DEVICE: SYNGO VOLUME PERFUSION-CT BODY
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K073373(ABBREVIATED)
ATTN: RALF HOFMANN PHONE NO : 499 191 188170
HENKESTRASSE 127 SE DECISION MADE: 18-DEC-07
ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARTISTE MV SA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072485(TRADITIONAL)
ATTN: ERIK RODRIGUEZ PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 27-DEC-07
SAN DIEGO, CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON X300 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072676(SPECIAL)
ATTN: MARTINA VOGT PHONE NO : 425-557-1434
1230 SHOREBIRD WAY SE DECISION MADE: 18-DEC-07
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STUDIODOP VICORDER
SKIDMORE MEDICAL, LIMITED 510(k) NO: K071730(ABBREVIATED)
ATTN: DAVID W WAGNER PHONE NO : 303-674-3070
7744 SWAPS TRAIL SE DECISION MADE: 20-DEC-07
EVERGREEN, CO 80439-6310 510(k) STATEMENT
DEVICE: SMH FLEX "S"
SMH BIOMATERIAL AG 510(k) NO: K073040(TRADITIONAL)
ATTN: ASHLEY TRUITT PHONE NO : 940-395-4555
3537 TEASLEY LANE SE DECISION MADE: 13-DEC-07
DENTON, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWINFIX FT PK
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K072785(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 10-DEC-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGION STEM WITH HOLES
SMITH & NEPHEW, INC. 510(k) NO: K072531(TRADITIONAL)
ATTN: MEGAN BEVILL PHONE NO : 901-399-5340
1450 BROOKS RD. SE DECISION MADE: 06-DEC-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOURNEY UNICONDYLAR FEMORAL IMPLANT
SMITH & NEPHEW, INC. 510(k) NO: K073175(ABBREVIATED)
ATTN: MARLON RIDLEY PHONE NO : 901-399-6055
1450 BROOKS RD. SE DECISION MADE: 20-DEC-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGION POROUS PRIMARY
SMITH & NEPHEW, INC. 510(k) NO: K073325(SPECIAL)
ATTN: RISHI SINHA PHONE NO : 901-399-6054
1450 BROOKS RD. SE DECISION MADE: 20-DEC-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPL
SMITHS MEDICAL MD, INC. 510(k) NO: K072657(TRADITIONAL)
ATTN: BRIAN HAUGSTAD PHONE NO : 651-628-7513
1265 GREY FOX RD. SE DECISION MADE: 14-DEC-07
ARDEN HILLS, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
SOFRADIM PRODUCTION 510(k) NO: K072951(SPECIAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060
150 GLOVER AVENUE SE DECISION MADE: 19-DEC-07
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTER-VU
SONOMED, INC. 510(k) NO: K073196(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-737-1703
377 ROUTE 17 S SE DECISION MADE: 19-DEC-07
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
SOPRO 510(k) NO: K070783(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 800-289-6367
124 GAITHER DRIVE SE DECISION MADE: 13-DEC-07
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: SCANORA 3D
SOREDEX PALODEX GROUP OY 510(k) NO: K073350(TRADITIONAL)
ATTN: JOUNI ONNELA PHONE NO : 358 457 8822204
NAHKELANTIE 160 SE DECISION MADE: 19-DEC-07
TUUSULA, FINLAND FIN-04300 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND
SPECTRANETICS CORP. 510(k) NO: K072750(SPECIAL)
ATTN: MICHAEL K HANDLEY PHONE NO : 719-447-2318
96 TALAMINE CT. SE DECISION MADE: 04-DEC-07
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCENT MAGNUM
SPINAL ELEMENTS, INC. 510(k) NO: K073348(SPECIAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 26-DEC-07
CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
SRA DEVELOPMENTS, LTD. 510(k) NO: K072961(TRADITIONAL)
ATTN: MICHAEL J.R. YOUNG PHONE NO : 44 136 4652426
BREMRIDGE HOUSE SE DECISION MADE: 19-DEC-07
ASHBURTON, DEVON, UNITED KINGDOM T510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSITE FUSION DYNAMIC REGISTRATION TOOL
ST. JUDE MEDICAL 510(k) NO: K071818(TRADITIONAL)
ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454
1350 ENERGY LN., SUITE 110 SE DECISION MADE: 20-DEC-07
ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2
STERIS CORPORATION 510(k) NO: K072510(ABBREVIATED)
ATTN: JOHN ROBERT SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 11-DEC-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
STRYKER CORP. 510(k) NO: K072118(TRADITIONAL)
ATTN: JEAN SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 07-DEC-07
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
STRYKER CORP. 510(k) NO: K072271(TRADITIONAL)
ATTN: BECKY DITTY PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 18-DEC-07
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANTIS SPINAL SYSTEM
STRYKER CORP. 510(k) NO: K073151(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8029
2 PEARL COURT SE DECISION MADE: 06-DEC-07
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
SYNERGETICS, INC 510(k) NO: K071482(TRADITIONAL)
ATTN: DAN REGAN PHONE NO : 636-794-5013
3845 CORPORATE CENTRE DRIVE SE DECISION MADE: 20-DEC-07
O'FALLON, MO 63368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 2.0MM TITANIUM T-PLATE
SYNTHES (USA) 510(k) NO: K072758(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 610-719-6920
1301 GOSHEN PKWY SE DECISION MADE: 18-DEC-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
SYNTHES (USA) 510(k) NO: K073186(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941
1301 GOSHEN PKWY SE DECISION MADE: 17-DEC-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORACLE SPACER, OPAL SPACER
SYNTHES SPINE 510(k) NO: K072791(TRADITIONAL)
ATTN: STACEY BONNELL PHONE NO : 610-719-5895
1302 WRIGHTS LANE EAST SE DECISION MADE: 26-DEC-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
SYSTEMSONE 510(k) NO: K073372(TRADITIONAL)
ATTN: THOMAS ARTHUR PHONE NO : 907-677-2618
6130 BLACKBERRY ST SE DECISION MADE: 07-DEC-07
STE B 510(k) SUMMARY AVAILABLE FROM FDA
ANCHORAGE, AK 99502 THIRD PARTY REVIEW
DEVICE: PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227,
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K072784(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 21-DEC-07
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: BELMONT QUOLIS 5000 SERIES DENTAL UNIT
TAKARA BELMONT USA, INC. 510(k) NO: K072273(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 20-DEC-07
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEUKO EZ VUE
TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K071712(TRADITIONAL)
ATTN: CHARLES PENNINGTON PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 04-DEC-07
BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSIGN LARYNGEAL ELECTRODES
THE MAGSTIM COMPANY LTD. 510(k) NO: K071349(TRADITIONAL)
ATTN: ANWEN EVANS PHONE NO : 44 199 4240798
SPRING GARDENS SE DECISION MADE: 12-DEC-07
WHITLAND 510(k) SUMMARY AVAILABLE FROM FDA
CARMARTHENSHIRE, WALES, UNITED KINGDOM SA34 OHR
DEVICE: BODYFORM THORACIC FIXATION SYSTEM
THEKEN SPINE LLC 510(k) NO: K072407(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-773-7677
283 E WATERLOO RD. SE DECISION MADE: 21-DEC-07
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREATININE (ENZYMATIC)
THERMO FISHER SCIENTIFIC OY 510(k) NO: K070824(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 329100
2 RATASTIE SE DECISION MADE: 03-DEC-07
VANTAA, FINLAND 01620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI SYSTEM DENTAL IMPLANTS
THOMMEN MEDICAL, AG 510(k) NO: K072649(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 06-DEC-07
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI ART ABUTMENT
THOMMEN MEDICAL, AG 510(k) NO: K073141(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 05-DEC-07
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WORKSTATIONONE BREAST IMAGING WORKSTATION
THREE PALM SOFTWARE, LLC 510(k) NO: K073272(TRADITIONAL)
ATTN: HEIDI D ZHANG PHONE NO : 408-356-3240
367 PENN WAY SE DECISION MADE: 11-DEC-07
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-1 ESTHETIC COMPOSITE SYSTEM
TOKUYAMA DENTAL CORPORATION 510(k) NO: K072746(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 04-DEC-07
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIDF-100A/B1 IMAGE PROCESSOR
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K073259(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 20-DEC-07
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
TRANSOMA MEDICAL 510(k) NO: K073147(SPECIAL)
ATTN: LISA STONE PHONE NO : 651-414-5521
4358 WEST ROUND LAKE RD. SE DECISION MADE: 03-DEC-07
ARDEN HILLS, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSS.BONE
TRIMED, INC. 510(k) NO: K071876(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 661-312-7150
25864 TOURNAMENT RD. SUITE A SE DECISION MADE: 17-DEC-07
VALENCIA, CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K073020(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY, E-110 SE DECISION MADE: 19-DEC-07
PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
VASCULAR SOLUTIONS, INC. 510(k) NO: K072810(TRADITIONAL)
ATTN: DORALIE POGANSKI PHONE NO : 763-656-4300
6464 SYCAMORE COURT SE DECISION MADE: 19-DEC-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
VASCULAR SOLUTIONS, INC. 510(k) NO: K073264(SPECIAL)
ATTN: JAMES CHAPMAN PHONE NO : 763-656-4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 07-DEC-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARICATH PERIPHERAL INFUSION CATHETER
VEINRX INC. 510(k) NO: K073400(SPECIAL)
ATTN: GREGORY MATHISON PHONE NO : 218-387-1559
8210 N.W. 27TH ST. SE DECISION MADE: 20-DEC-07
MIAMI, FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
VISION-SCIENCES, INC. 510(k) NO: K072180(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 18-DEC-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340
WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K072009(TRADITIONAL)
ATTN: ECKHARDT ALBERS PHONE NO : 011 49 4054702180
KRONSAALSWEG 40 SE DECISION MADE: 14-DEC-07
HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
WELCH ALLYN, INC. 510(k) NO: K070060(TRADITIONAL)
ATTN: JOHN SAWYER PHONE NO : 315-685-4571
4341 STATE STREET ROAD SE DECISION MADE: 18-DEC-07
PO BOX 220 510(k) SUMMARY AVAILABLE FROM FDA
SKANEATELES FALLS, NY 13153-0220
DEVICE: OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K072168(TRADITIONAL)
ATTN: JENNY HSIEH PHONE NO : 886 229 282112
1FL, NO.16, LANE 454 SE DECISION MADE: 19-DEC-07
JUNGJENG RD. 510(k) SUMMARY AVAILABLE FROM FDA
YUNGHE CITY, TAIPEI COUNTY, CHINA (TAIWAN)
DEVICE: DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K071122(ABBREVIATED)
ATTN: HSUN-HUI HUANG PHONE NO : 886 285 093976
BIHE INDUSTRY AREA SE DECISION MADE: 12-DEC-07
YITANG TOWN, PIZHOU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA
JIANGSU, CHINA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VE
XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K072314(ABBREVIATED)
ATTN: HSUN- HUI HUANG PHONE NO : 886 285 093976
BIHE INDUSTRY AREA SE DECISION MADE: 12-DEC-07
YITANG TOWN, PIZHOU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA
JIANGSU, CHINA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K072377(ABBREVIATED)
ATTN: HSUN-HUI HUANG PHONE NO : 886 285 093976
BIHE INDUSTRY AREA SE DECISION MADE: 14-DEC-07
YITANG TOWN, PIZHOU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA
JIANGSU, CHINA
DEVICE: MODIFICATION TO: LOCATOR IMPLANT ANCHOR
ZEST ANCHORS, INC. 510(k) NO: K072878(SPECIAL)
ATTN: RICHARD OVERTON PHONE NO : 760-743-7744
2061 WINERIDGE PL. SE DECISION MADE: 03-DEC-07
ESCONDIDO, CA 92029 510(k) STATEMENT
DEVICE: ATHENA MULTI-LYTE GBM TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K071219(TRADITIONAL)
ATTN: EWA NADOLCZAK PHONE NO : 908-243-4924
200 EVANS WAY SE DECISION MADE: 06-DEC-07
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: ELITE GLASS
ZHERMACK S.P.A. 510(k) NO: K073005(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 12-DEC-07
BEND, OR 97702 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 265
TOTAL WITH SUMMARIES 243
TOTAL WITH STATEMENTS 22
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