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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K240298
Device Name Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
Applicant
Bionova Medical, Inc.
3012 Centre Oak Way
Suite 102
Germantown,  TN  38138
Applicant Contact Alex Greene
Correspondent
RQM+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Lucie Dalet
Classification Product Code
FRO  
Date Received02/01/2024
Decision Date 08/21/2024
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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