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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 K162752
Device Name ARTIA Reconstructive Tissue Matrix Perforated
Applicant
Lifecell Corporation
One Millennium Way
Branchburg,  NJ  08876
Applicant Contact ANUJA YARDI
Correspondent
Lifecell Corporation
One Millennium Way
Branchburg,  NJ  08876
Correspondent Contact ANUJA YARDI
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXH  
Date Received09/30/2016
Decision Date 02/24/2017
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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