K-number	K133155
Device name	HYDROPHILIC COATED GUIDEWIRE
Applicant	Lake Region Medical
Product code	DQX
Device class	Class II
Decision date	Apr 7, 2014
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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HYDROPHILIC COATED GUIDEWIRE

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