Name: Predicase
Price: 199 USD

K-number	K092040
Device name	PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240
Applicant	R4 Vascular, Inc.
Product code	LJS
Device class	Class II
Decision date	Nov 18, 2009
Decision	Substantially Equivalent
Regulation	880.5970

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Source

View the full FDA submission: accessdata.fda.gov

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PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240

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