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510(k) K171600

Renal Access Cobra Catheter, Kumpe Access Catheter by Cook Incorporated — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2018
Date Received
June 1, 2017
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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