K-number	K141696
Device name	EDWARDS ESHEATH INTRODUCER SET
Applicant	Edwards Lifesciences
Product code	DYB
Device class	Class II
Decision date	Sep 18, 2014
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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EDWARDS ESHEATH INTRODUCER SET

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