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510(k) K190903

Lawson Retrograde Nephrostomy Wire Puncture Set by Cook Incorporated — Product Code LJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2019
Date Received
April 8, 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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