K-number	K980977
Device name	PIOLAX HYDROPHILIC GUIDEWIRE
Applicant	Piolax Medical Devices, Inc.
Product code	DQX
Device class	Class II
Decision date	Oct 27, 1998
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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PIOLAX HYDROPHILIC GUIDEWIRE

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