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510(k) K181713

Ultraxx Nephrostomy Balloon Catheter Set by Cook Incorporated — Product Code LJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2018
Date Received
June 28, 2018
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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