Device Classification Name |
mesh, surgical, collagen, large abdominal wall defects
|
510(k) Number |
K121289 |
Device Name |
LTM-LABAROSCOPIC SURGICAL MESH |
Applicant |
LIFECELL CORP. |
ONE MILLENNIUM WAY |
BRANCHBURG,
NJ
08876
|
|
Applicant Contact |
MARK R JAKUBOWSKI |
Correspondent |
LIFECELL CORP. |
ONE MILLENNIUM WAY |
BRANCHBURG,
NJ
08876
|
|
Correspondent Contact |
MARK R JAKUBOWSKI |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/30/2012 |
Decision Date | 08/03/2012 |
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
|