K-number	K061000
Device name	EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
Applicant	Cook Vascular, Inc.
Product code	DRE
Device class	Class II
Decision date	May 10, 2006
Decision	Substantially Equivalent
Regulation	870.1310

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View the full FDA submission: accessdata.fda.gov

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EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0

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