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510(k) K181144

Angled Tip Ureteral Catheter by Cook Incorporated — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2018
Date Received
May 1, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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