K-number	K161815
Device name	FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
Applicant	Genesee Biomedical, Inc.
Product code	KRH
Device class	Class II
Decision date	Oct 12, 2016
Decision	Substantially Equivalent
Regulation	870.3800

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Source

View the full FDA submission: accessdata.fda.gov

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FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

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