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510(k) K191498

Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc by Cook Incorporated — Product Code LJE

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 29, 2020
Date Received
June 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

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