Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K093166 |
Device Name |
WITTMANN PATCH |
Applicant |
APERTA LLC |
990 GULF WINDS WAY |
CASEY KEY NOKOMIS,
FL
34275
|
|
Applicant Contact |
DIETMAR H WITTMANN |
Correspondent |
APERTA LLC |
990 GULF WINDS WAY |
CASEY KEY NOKOMIS,
FL
34275
|
|
Correspondent Contact |
DIETMAR H WITTMANN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/06/2009 |
Decision Date | 12/07/2009 |
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
|
Recalls |
CDRH Recalls
|