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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 K140510
Device Name MIROMATRIX WOUND MATRIX
Applicant
Miromatrix Medical, Inc.
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Applicant Contact STEPHEN RHODES
Correspondent
Miromatrix Medical, Inc.
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact STEPHEN RHODES
Classification Product Code
KGN  
Date Received02/28/2014
Decision Date 06/19/2014
Decision Substantially Equivalent (SESE)
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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