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510(k) K172588

Balloon Catheter and Balloon Ureteral Dilator Set by Cook Incorporated — Product Code EZN

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 19, 2018
Date Received
August 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

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