K-number	K181669
Device name	ConvertX Biliary Stent System
Applicant	Brightwater Medical
Product code	FGE
Device class	Class II
Decision date	Mar 14, 2019
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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ConvertX Biliary Stent System

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