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510(k) K223469

WallFlex™ Biliary RX Stent System by Boston Scientific Corporation — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
June 15, 2023
Date Received
November 17, 2022
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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