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510(k) K191609

Tria Soft Ureteral Stent by Boston Scientific Corporation — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2019
Date Received
June 17, 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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