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510(k) K191446

Ureteral Stent Systems, Biliary Drainage Catheters by Boston Scientific Corporation — Product Code FAD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 2, 2020
Date Received
May 31, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

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