Name: Predicase
Price: 199 USD

K-number	K083146
Device name	ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
Applicant	Asahi Intecc Co., Ltd.
Product code	DQX
Device class	Class II
Decision date	Nov 21, 2008
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000

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