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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, balloon, dilation of cervical canal prior to labor
510(k) Number K143424
Device Name UTAH CVX-RIPE
Applicant
UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE,  UT  84047 -1048
Applicant Contact Ben Shirley
Correspondent
UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE,  UT  84047 -1048
Correspondent Contact Ben Shirley
Regulation Number884.4260
Classification Product Code
PFJ  
Date Received12/01/2014
Decision Date 08/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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