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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 K210580
Device Name InnovaMatrix FS
Applicant
Triad Life Sciences, Inc.
1770 Moriah Woods Blvd., Suite 18
Memphis,  TN  38117
Applicant Contact Jon G. Hargis
Correspondent
Streamline Regulatory
3502 Dundee Dr.way
Chevy Chase,  MD  20815
Correspondent Contact Stephen P. Rhodes
Classification Product Code
KGN  
Date Received02/26/2021
Decision Date 04/21/2021
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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