K-number	K162404
Device name	Express SD Biliary Monorail Premounted Stent System
Applicant	Boston Scientific Corporation
Product code	FGE
Device class	Class II
Decision date	Oct 12, 2016
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Express SD Biliary Monorail Premounted Stent System

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