510(k) K173687

Strange Bile Duct Stone Exploration Set by Cook Incorporated — Product Code LQR

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 15, 2017
Date Received
December 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type