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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K954619
Device Name CORDGUARD II
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Applicant Contact KEVIN L CORNWELL
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Correspondent Contact KEVIN L CORNWELL
Regulation Number884.4530
Classification Product Code
KNA  
Date Received10/05/1995
Decision Date 12/21/1995
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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