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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, Collagen, Plastic And Reconstructive Surgery
510(k) Number K160400
Device Name Miromatrix Biological Mesh
Applicant
Miromatrix Medical, Inc.
10399 W. 70th St.
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
OXH  
Subsequent Product Code
FTM  
Date Received02/12/2016
Decision Date 06/08/2016
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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