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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K905263
Device Name UTAH ESSU
Applicant
UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE,  UT  84047 -1048
Applicant Contact EDWIN O GOODMAN
Correspondent
UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE,  UT  84047 -1048
Correspondent Contact EDWIN O GOODMAN
Regulation Number884.4120
Classification Product Code
HGI  
Date Received11/23/1990
Decision Date 09/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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