K-number	K083191
Device name	DETLOGIX ANNULOPLASTY RING, MODEL: 5100
Applicant	Edwards Lifesciences, LLC
Product code	KRH
Device class	Class II
Decision date	Apr 10, 2009
Decision	Substantially Equivalent
Regulation	870.3800

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View the full FDA submission: accessdata.fda.gov

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DETLOGIX ANNULOPLASTY RING, MODEL: 5100

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