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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 K130817
Device Name LTN - LAPAROSCOPIC SURGICAL MESH
Applicant
LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG,  NJ  08876
Applicant Contact JOHN BLEWITT
Correspondent
LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG,  NJ  08876
Correspondent Contact JOHN BLEWITT
Regulation Number878.3300
Classification Product Code
OXK  
Subsequent Product Code
FTM  
Date Received03/25/2013
Decision Date 04/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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