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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 K162570
Device Name Miromatrix Biological Mesh TW
Applicant
Miromatrix Medical, Inc.
18683 Bearpath Trl.
Eden Prairie,  MN  55344
Applicant Contact Jeff Ross
Correspondent
Biologics Consulting Group, Inc.
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Miriam C. Provost
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OWW  
Date Received09/15/2016
Decision Date 02/16/2017
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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