Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K955494 |
Device Name |
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES |
Applicant |
W.L. GORE & ASSOCIATES,INC |
3750 W. KILTIE LN. |
FLAGSTAFF,
AZ
86001 -0900
|
|
Applicant Contact |
JOHN W NICHOLSON |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
3750 W. KILTIE LN. |
FLAGSTAFF,
AZ
86001 -0900
|
|
Correspondent Contact |
JOHN W NICHOLSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/01/1995 |
Decision Date | 01/24/1996 |
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
|