K-number	K210949
Device name	Foundation Dermal Regeneration Scaffold (DRS) Solo
Applicant	Bionova Medical, Inc.
Product code	KGN
Device class	Class U
Decision date	Aug 11, 2022
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Foundation Dermal Regeneration Scaffold (DRS) Solo

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