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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 K170763
Device Name Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
Applicant
Acell, Inc.
6640 Eli Whitney Dr.
Columbia,  MD  21046
Applicant Contact Salman Elmi
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact John J. Smith
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OXH   OXK  
Date Received03/13/2017
Decision Date 06/08/2017
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
Recalls CDRH Recalls
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