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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K970077
Device Name LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Applicant Contact NADEEM AHMED
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Correspondent Contact NADEEM AHMED
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received01/09/1997
Decision Date 05/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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