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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 K941251
Device Name FINESSE IEC/601
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Applicant Contact ED GOODMAN
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Correspondent Contact ED GOODMAN
Regulation Number884.4120
Classification Product Code
HGI  
Date Received03/15/1994
Decision Date 12/12/1994
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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