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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
Device Name LTM-LABAROSCOPIC SURGICAL MESH
Applicant
Lifecell Corp.
One Millennium Way
Branchburg,  NJ  08876
Applicant Contact MARK R JAKUBOWSKI
Correspondent
Lifecell Corp.
One Millennium Way
Branchburg,  NJ  08876
Correspondent Contact MARK R JAKUBOWSKI
Regulation Number878.3300
Classification Product Code
OXK  
Date Received04/30/2012
Decision Date 08/03/2012
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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