K-number	K180756
Device name	Safety Wire Guide Introducer
Applicant	Cook Incorporated
Product code	EZN
Device class	Class II
Decision date	May 24, 2018
Decision	Substantially Equivalent
Regulation	876.5470

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Source

View the full FDA submission: accessdata.fda.gov

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Safety Wire Guide Introducer

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