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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 K141084
Device Name Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
Applicant
ACELL, INC
6640 ELI WHITNEY DR
SUITE 200
COLUMBIA,  MD  21046
Applicant Contact Salman Elmi
Correspondent
ACELL, INC
6640 ELI WHITNEY DR
SUITE 200
COLUMBIA,  MD  21046
Correspondent Contact Salman Elmi
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXH  
Date Received04/28/2014
Decision Date 06/17/2015
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
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