Name: Predicase
Price: 199 USD

K-number	K083627
Device name	WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
Applicant	Boston Scientific Corporation
Product code	FGE
Device class	Class II
Decision date	Apr 7, 2009
Decision	Unknown
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540

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