K-number	K093554
Device name	RETROFLEX DILATOR KIT
Applicant	Edwards Lifesciences, LLC
Product code	DRE
Device class	Class II
Decision date	Apr 13, 2010
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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RETROFLEX DILATOR KIT

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