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510(k) K182695

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter by Cook Incorporated — Product Code EYB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 17, 2019
Date Received
September 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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