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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K171604
Device Name Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
Applicant
Cook Incorporated
450 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Ian Herrman
Correspondent
Cook Incorporated
450 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Ian Herrman
Regulation Number884.4530
Classification Product Code
LKF  
Date Received06/01/2017
Decision Date 02/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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