Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K926478 |
Device Name |
GORE-TEK(R) SOFT TISSUE PATCH |
Applicant |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
P.O. BOX 500 |
FLAGSTAFF,
AZ
86002
|
|
Applicant Contact |
THOMAS O'HARA |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
P.O. BOX 500 |
FLAGSTAFF,
AZ
86002
|
|
Correspondent Contact |
THOMAS O'HARA |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/29/1992 |
Decision Date | 11/29/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|