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510(k) K183323

UPJ Occlusion Balloon Catheter by Cook Incorporated — Product Code EYB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
August 5, 2019
Date Received
November 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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