K-number	K992237
Device name	MEDTRONIC GT2 FUSION GUIDE WIRES
Applicant	Medtronic Vascular
Product code	DQX
Device class	Class II
Decision date	Sep 9, 1999
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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MEDTRONIC GT2 FUSION GUIDE WIRES

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