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510(k) K182709

One-Step Suprapubic Introducer by Cook Incorporated — Product Code KOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2018
Date Received
September 27, 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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