K-number	K082304
Device name	ROLL-X GUIDEWIRE
Applicant	St Jude Medical
Product code	DQX
Device class	Class II
Decision date	Aug 27, 2008
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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ROLL-X GUIDEWIRE

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