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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 K213716
Device Name InnovaBurn
Applicant
Triad Life Sciences, Inc.
1770 Moriah Woods Blvd., Suite 18
Memphis,  TN  38117
Applicant Contact Bill Willis
Correspondent
Triad Life Sciences, Inc.
1770 Moriah Woods Blvd., Suite 18
Memphis,  TN  38117
Correspondent Contact Donna Best
Classification Product Code
KGN  
Date Received11/24/2021
Decision Date 09/29/2022
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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