K-number	K081337
Device name	APPROACH CTO WIRE GUIDE
Applicant	Cook Incorporated
Product code	DQX
Device class	Class II
Decision date	Aug 8, 2008
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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APPROACH CTO WIRE GUIDE

Everything you need for a 510(k) submission. Nothing you don't.