LIFECELL TISSUE EXPANDER


Device Classification Name

expander, skin, inflatable

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

Correspodent Contact kristen meany
Classification Product Code
LCJ  
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