Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K053158 |
Device Name |
OPTILENE MESH LP |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
MATTHEW M HULL |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
MATTHEW M HULL |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/14/2005 |
Decision Date | 01/18/2006 |
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
|
|
|