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510(k) K173654

Ureteral Dilator Sets, Ureteral Dilators by Cook Incorporated — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2018
Date Received
November 28, 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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