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510(k) K181097

Cook Cystostomy Catheter Set by Cook Incorporated — Product Code KOB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 18, 2019
Date Received
April 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

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