Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K964761 |
Device Name |
S.A.M. FACIAL IMPLANT W/INTRODUCER |
Applicant |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Applicant Contact |
JOHN W NICHOLSON |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Correspondent Contact |
JOHN W NICHOLSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/27/1996 |
Decision Date | 01/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|