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510(k) K181971

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set by Cook Incorporated — Product Code FAD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 23, 2019
Date Received
July 24, 2018
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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