K-number	K171513
Device name	Lunderquist Extra Stiff Wire Guide
Applicant	William Cook Europe Aps
Product code	DQX
Device class	Class II
Decision date	Dec 7, 2017
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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Lunderquist Extra Stiff Wire Guide

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