K-number	K890807
Device name	GUIDE WIRE INTRODUCER
Applicant	Datascope Corp.
Product code	DQX
Device class	Class II
Decision date	Jun 20, 1989
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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GUIDE WIRE INTRODUCER

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