K-number	K163169
Device name	Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
Applicant	Cook Ireland, Ltd.
Product code	FGE
Device class	Class II
Decision date	Feb 7, 2017
Decision	Unknown
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

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