Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K082216 |
Device Name |
TBD ETHICON MESH |
Applicant |
ETHICON INC. |
ROUTE 22 WEST |
PO BOX 151 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
BRYAN A LISA |
Correspondent |
ETHICON INC. |
ROUTE 22 WEST |
PO BOX 151 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
BRYAN A LISA |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/06/2008 |
Decision Date | 09/05/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|