K-number	K232655
Device name	Bonvadis®
Applicant	Stemcyte, Inc.
Product code	FRO
Device class	Class U
Decision date	May 22, 2024
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Bonvadis®

Everything you need for a 510(k) submission. Nothing you don't.