K-number	K232599
Device name	TransForm McCarthy Mitral Annuloplasty Ring (TF)
Applicant	Genesee Biomedical, Inc.
Product code	KRH
Device class	Class II
Decision date	Apr 9, 2024
Decision	Substantially Equivalent
Regulation	870.3800

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Source

View the full FDA submission: accessdata.fda.gov

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TransForm McCarthy Mitral Annuloplasty Ring (TF)

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