K-number	K822586
Device name	TEFLON COATED GUIDE WIRES & CATHETER
Applicant	Universal Medical Instrument Corp.
Product code	DQX
Device class	Class II
Decision date	Oct 18, 1982
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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TEFLON COATED GUIDE WIRES & CATHETER

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