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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 K182259
Device Name Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
Applicant
Acell, Inc.
6640 Eli Whitney Dr.
Suite 200
Columbia,  MD  21046
Applicant Contact Andrea Artman
Correspondent
Acell, Inc.
6640 Eli Whitney Dr.
Suite 200
Columbia,  MD  21046
Correspondent Contact Andrea Artman
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWV   OXH  
Date Received08/21/2018
Decision Date 02/07/2019
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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