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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 K955508
Device Name ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact RICK LYKINS
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact RICK LYKINS
Regulation Number884.4530
Classification Product Code
LKF  
Date Received12/01/1995
Decision Date 02/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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