Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K080442 |
Device Name |
SERISCAFFOLD SURGICAL MESH |
Applicant |
SERICA TECHNOLOGIES, INC. |
200 BOSTON AVENUE |
SUITE 3700 |
MEDFORD,
MA
02155
|
|
Applicant Contact |
CONNIE H GARRISON |
Correspondent |
SERICA TECHNOLOGIES, INC. |
200 BOSTON AVENUE |
SUITE 3700 |
MEDFORD,
MA
02155
|
|
Correspondent Contact |
CONNIE H GARRISON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/19/2008 |
Decision Date | 11/13/2008 |
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
|