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510(k) K182066

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set by Cook Incorporated — Product Code KOB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 30, 2018
Date Received
August 1, 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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