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510(k) K160217

uVue HSG/SHG Catheter by Cook Incorporated — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2016
Date Received
January 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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