K-number	K942333
Device name	SCIMED EN TRE' III PTCA GUIDE WIRE
Applicant	Scimed Life Systems, Inc.
Product code	DQX
Device class	Class II
Decision date	Aug 31, 1994
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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SCIMED EN TRE' III PTCA GUIDE WIRE

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