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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 K041062
Device Name INTRAUTERINE VENOGRAM NEEDLE SET
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Applicant Contact CINDY RUMPLE
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Correspondent Contact CINDY RUMPLE
Regulation Number884.4530
Classification Product Code
LKF  
Date Received04/23/2004
Decision Date 10/01/2004
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
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