Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K063739 |
Device Name |
SEPRAMESH, MODEL 5959-1214 |
Applicant |
GENZYME CORPORATION |
500 KENDALL STREET |
CAMBRIDGE,
MA
02142
|
|
Applicant Contact |
MATTHEW HIBBERT |
Correspondent |
GENZYME CORPORATION |
500 KENDALL STREET |
CAMBRIDGE,
MA
02142
|
|
Correspondent Contact |
MATTHEW HIBBERT |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/18/2006 |
Decision Date | 01/17/2007 |
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
|