K-number	K192762
Device name	Physio Flex Annuloplasty Ring
Applicant	Edwards Lifesciences, LLC
Product code	KRH
Device class	Class II
Decision date	Dec 16, 2019
Decision	Substantially Equivalent
Regulation	870.3800

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Source

View the full FDA submission: accessdata.fda.gov

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Physio Flex Annuloplasty Ring

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