K-number	K952860
Device name	THE NINER NITINOL GUIDEWIRE
Applicant	Microvena Corp.
Product code	DQX
Device class	Class II
Decision date	Dec 13, 1995
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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THE NINER NITINOL GUIDEWIRE

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