Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K922452 |
Device Name |
GORE-TEX SOFT TISSUE PATCH PLUS |
Applicant |
W.L. GORE & ASSOCIATES,INC |
3750 WEST KILTIE LN. DOCK-A |
P.O. BOX 900 |
FLAGSTAFF,
AR
86002
|
|
Applicant Contact |
THOM O'HARA |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
3750 WEST KILTIE LN. DOCK-A |
P.O. BOX 900 |
FLAGSTAFF,
AR
86002
|
|
Correspondent Contact |
THOM O'HARA |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/26/1992 |
Decision Date | 09/29/1994 |
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
|