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510(k) K163018

Zilver 635 Biliary Stent by Cook Ireland, Ltd. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
December 23, 2016
Date Received
October 31, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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  • K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Bilia (February 27, 2018)

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