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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 S. 300 W.
Midvale,  UT  84047
Applicant Contact Ben Shirley
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
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
Predetermined Change
Control Plan Authorized		 No
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