K-number	K152607
Device name	Express SD Biliary Monorail Premounted Stent System
Applicant	Boston Scientific
Product code	FGE
Device class	Class II
Decision date	Oct 27, 2015
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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