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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 K943448
Device Name LUMIN
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Applicant Contact GAIL BILLINGS
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Correspondent Contact GAIL BILLINGS
Regulation Number884.4530
Classification Product Code
LKF  
Date Received07/18/1994
Decision Date 04/11/1995
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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