K-number	K060034
Device name	NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
Applicant	Nipro Medical Corporation
Product code	OCY
Device class	Class II
Decision date	Feb 28, 2006
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE

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