Home / 510(k) Clearances / K171604

510(k) K171604

Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip by Cook Incorporated — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2018
Date Received
June 1, 2017
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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