K-number	K960563
Device name	SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
Applicant	Scimed Life Systems, Inc.
Product code	DQX
Device class	Class II
Decision date	Apr 29, 1996
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES

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