Device Classification Name |
tissue expander and accessories
|
510(k) Number |
K112534 |
Device Name |
LIFECELL TISSUE EXPANDER |
Applicant |
LIFECELL CORP. |
ONE MILLENNIUM WAY |
BRANCHBURG,
NJ
08876
|
|
Applicant Contact |
KRISTEN MEANY |
Correspondent |
LIFECELL CORP. |
ONE MILLENNIUM WAY |
BRANCHBURG,
NJ
08876
|
|
Correspondent Contact |
KRISTEN MEANY |
Classification Product Code |
|
Date Received | 09/01/2011 |
Decision Date | 08/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|