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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 K150712
Device Name LTM-Perforated Surgical Mesh
Applicant
Lifecell Corporation
One Millennium Way
Branchburg,  NJ  08876
Applicant Contact Linda Scamardella
Correspondent
Lifecell Corporation
One Millennium Way
Branchburg,  NJ  08876
Correspondent Contact Linda Scamardella
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/19/2015
Decision Date 07/02/2015
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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