Name: Predicase
Price: 199 USD

K-number	K032810
Device name	DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
Applicant	Medtronic Heart Valves
Product code	KRH
Device class	Class II
Decision date	Dec 5, 2003
Decision	Substantially Equivalent
Regulation	870.3800

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Source

View the full FDA submission: accessdata.fda.gov

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DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE

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