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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, collagen, large abdominal wall defects
510(k) Number K121289
Model SIZES RANGINF FROM 2 CM X 2 CM TO 20 CM X 30 CM
Device Name LTM-LABAROSCOPIC SURGICAL MESH
Original Applicant
LIFECELL CORP.
one millennium way
branchburg,  NJ  08876
Original Contact mark r jakubowski
Regulation Number878.3300
Classification Product Code
OXK  
Date Received04/30/2012
Decision Date 08/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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