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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 K210949
Device Name Foundation Dermal Regeneration Scaffold (DRS) Solo
Applicant
Bionova Medical, Inc.
3012 Centre Oak Way
Suite 102
Germantown,  TN  38138
Applicant Contact Alex Greene
Correspondent
Bionova Medical, Inc.
3012 Centre Oak Way
Suite 102
Germantown,  TN  38138
Correspondent Contact Alex Greene
Classification Product Code
KGN  
Date Received03/30/2021
Decision Date 08/11/2022
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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