Device Classification Name |
mesh, surgical
|
510(k) Number |
K894580 |
Device Name |
GORE-TEX SURGICAL TAPE |
Applicant |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
P.O. BOX 500 |
FLAGSTAFF,
AZ
86002
|
|
Applicant Contact |
CRAIG NEWMAN |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
P.O. BOX 500 |
FLAGSTAFF,
AZ
86002
|
|
Correspondent Contact |
CRAIG NEWMAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/24/1989 |
Decision Date | 10/10/1989 |
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
|
|
|