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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K082176
Device Name LTM-BPS SURGICAL MESH
Applicant
LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG,  NJ  08876
Applicant Contact LORRAINE T MONTEMURRO
Correspondent
LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG,  NJ  08876
Correspondent Contact LORRAINE T MONTEMURRO
Regulation Number878.3300
Classification Product Code
FTM  
Date Received08/01/2008
Decision Date 11/14/2008
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
Predetermined Change
Control Plan Authorized		 No
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