K-number	K012216
Device name	NIROYAL BILIARY PREMOUNTED STENT SYSTEM
Applicant	Boston Scientific Scimed, Inc.
Product code	FGE
Device class	Class II
Decision date	Aug 17, 2001
Decision	Unknown
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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NIROYAL BILIARY PREMOUNTED STENT SYSTEM

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