Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K926565 |
Device Name |
GORE-TEX(TM) DUAL MESH |
Applicant |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
P.O. BOX 500 |
FLAGSTAFF,
AZ
86002
|
|
Applicant Contact |
JOHN W NICHOLSON |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
P.O. BOX 500 |
FLAGSTAFF,
AZ
86002
|
|
Correspondent Contact |
JOHN W NICHOLSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/31/1992 |
Decision Date | 09/09/1993 |
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
|
|
|