FDA 510(k) Applications for Medical Device:
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K200566 | Admedus Regen Pty Ltd |
26 Harris Road | Malaga | 6080 | |
| K162579 | Admedus Regen Pty Ltd |
26 Harris Road | Malaga | 6090 | |
| K151865 | AESCULAP, INC. |
3773 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034 |
| K060396 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K992776 | ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. | HUDSON | NH | 03051 |
| K971726 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K983602 | BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K041716 | BOSTON SCIENTIFIC CORP. |
TWO SCIMED PLACE | MAPLE GROVE | MN | 55311-1566 |
| K994032 | BRIDGER BIOMED, INC. |
2430 NORTH 7TH AVE., SUITE 4 | BOZEMAN | MT | 59715 |
| K973178 | BRIDGER BIOMED, INC. |
2430 NORTH 7TH AVE., SUITE 4 | BOZEMAN | MT | 59715 |
| K130872 | CELXCEL PTY LTD |
1801 ROCKVILLE PIKE, SUITE 300 | ROCKVILLE | MD | 20852 |
| K021129 | CHASE MEDICAL, INC. |
1710 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K012248 | CHASE MEDICAL, INC. |
1704 ENTERPRISE DR. | ATHENS | TX | 75751 |
| K001662 | CHASE MEDICAL, INC. |
1710 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K003467 | CHASE MEDICAL, INC. |
1876 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K020132 | CHASE MEDICAL, INC. |
1710 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K020233 | CHASE MEDICAL, INC. |
1710 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K022093 | CHASE MEDICAL, INC. |
1876 FIRMAN DR. | RICHARDSON | TX | 75081 |
| K001785 | COOK BIOTECH, INC. |
3055 KENT AVE. | WEST LAFAYETTE | IN | 47906-1076 |
| K140789 | CORMATRIX CARDIOVASCULAR, INC. |
1100 OLD ELLIS ROAD | ROSWELL | GA | 30076 |
| K063349 | CORMATRIX CARDIOVASCULAR, INC. |
155 MOFFETT PARK DRIVE | SUNNYVALE | CA | 94089 |
| K152127 | CORMATRIX CARDIOVASCULAR, INC. |
1100 OLD ELLIS ROAD | ROSWELL | GA | 30076 |
| K111187 | CORMATRIX CARDIOVASCULAR, INC. |
155 MOFFETT PARK DRIVE | SUNNYVALE | CA | 94089 |
| K051405 | CORMATRIX CARDIOVASCULAR, INC. |
155 MOFFETT PARK DRIVE | SUNNYVALE | CA | 94089 |
| K091626 | CRYOLIFE, INC. |
1655 ROBERTS BLVD., N.W. | KENNESAW | GA | 30144 |
| K101866 | CRYOLIFE, INC. |
1655 ROBERTS BLVD., N.W. | KENNESAW | GA | 30144 |
| K162506 | CryoLife, Inc. |
1655 Roberts Blvd., N.W. | Kennesaw | GA | 30144 |
| K082139 | EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY | IRVINE | CA | 92614 |
| K003070 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K963967 | GLYCAR, INC. |
4537 BELCLAIRE AVE. | DALLAS | TX | 75205 |
| K963368 | GLYCAR, INC. |
3003 LBJ FREEWAY | DALLAS | TX | 75234 |
| K052416 | HANCOCK/JAFFE LABORATORIES |
2807 MCGAW AVE. | IRVINE | CA | 92614 |
| K101740 | LEMAITRE VASCULAR, INC. |
63 2ND AVENUE | BURLINGTON | MA | 01803 |
| K081438 | LifeNet Health |
1864 CONCERT DR. | VIRGINIA BEACH | VA | 23453 |
| K090637 | MAST BIOSURGERY USA INC. |
6749 TOP GUN ST., SUITE C | SAN DIEGO | CA | 92121 |
| K962342 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. | OAKLAND | NJ | 07436 |
| K955349 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. | OAKLAND | NJ | 07436 |
| K041736 | PERITEC BIOSCIENCES, LLC. |
3291 BREMERTON ROAD | CLEVELAND | OH | 44124 |
| K031948 | PM DEVICES, INC. |
2135-13700 MAYFIELD PLACE | RICHMOND, BC | V6V 2E4 | |
| K974914 | SHELHIGH, INC. |
P.O. BOX 884 | MILLBURN | NJ | 07041 |
| K982810 | SHELHIGH, INC. |
67 E. WILLOW ST. | MILLBURN | NJ | 07041 |
| K964467 | SHELHIGH, INC. |
67 E. WILLOW ST. | MILLBURN | NJ | 07041 |
| K112683 | SOLIMAS MEDICAL, INC. |
443 COSTA MESA TERRACE | SUNNYVALE | CA | 94089 |
| K122105 | SOLINAS MEDICAL INC |
443 COSTA MESA TERRACE | SUNNY VALE | CA | 94089 |
| K031586 | SOMANETICS CORP. |
1653 EAST MAPLE RD. | TROY | MI | 48083-4208 |
| K040162 | SOMANETICS CORP. |
1653 EAST MAPLE RD. | TROY | MI | 48083-4208 |
| K011487 | SOMANETICS CORP. |
1653 EAST MAPLE RD. | TROY | MI | 48083-4208 |
| K972201 | SULZER CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K993288 | SULZER CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K142461 | Synovis Life Technologies Inc. |
2575 University Ave. W. | St. Paul | MN | 55129 |
| K142447 | Synovis Life Technologies. Inc. |
2575 University Ave. W. | St. Paul | MN | 55129 |
| K040415 | SYNOVIS SURGICAL INNOVATIONS |
2575 UNIVERSITY AVE. WEST | ST. PAUL | MN | 55114-1024 |
| K122306 | SYNOVIS SURGICAL INNOVATIONS |
2575 UNIVERSITY AVE. | ST. PAUL | MN | 55114-1024 |
| K200955 | Vascutek Ltd |
Newmains Avenue | Inchinnan | PA4 9RR | |
| K963611 | VASCUTEK LTD. |
1300 EAST ANDERSON LN. | AUSTIN | TX | 78752 |
| K984526 | W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. | FLAGSTAFF | AZ | 86002-0500 |
| K012098 | W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD | ELKTON | MD | 21922-1408 |
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