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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K143426
Device Name Wound Matrix TF
Applicant
Miromatrix Medical, Inc.
18683 Bearpath Trl.
Eden Prairie,  MN  55347
Applicant Contact Jeff Ross
Correspondent
Biologics Consulting Group, Inc.
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Stephen Rhodes
Classification Product Code
KGN  
Date Received12/01/2014
Decision Date 01/27/2015
Decision Substantially Equivalent (SESE)
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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