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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 K162554
Device Name Gentrix Surgical Matrix
Applicant
Acell, Inc.
6640 Eli Whitney Drive
Columbia,  MD  21046
Applicant Contact Salman Elmi
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXH  
Date Received09/13/2016
Decision Date 10/21/2016
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
Predetermined Change
Control Plan Authorized		 No
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