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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
LCJ  
Date Received09/01/2011
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
Predetermined Change
Control Plan Authorized		 No
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