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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Uterine Contraction, External (For Use In Clinic)
510(k) Number K920152
Device Name BUBBLE TOCO
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Applicant Contact EDWIN O GOODMAN
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Correspondent Contact EDWIN O GOODMAN
Regulation Number884.2720
Classification Product Code
HFM  
Date Received01/13/1992
Decision Date 05/26/1993
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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