K-number	K133076
Device name	NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
Applicant	Neometrics, Inc.
Product code	OCY
Device class	Class II
Decision date	Feb 20, 2014
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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NOVAGOLD HIGH PERFORMANCE GUIDEWIRE

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