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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Home Uterine Activity Monitor
510(k) Number K020390
Device Name MODIFICATION TO FETAL ASSIST
Applicant
Huntleigh Diagnostics , Ltd.
40 Christopher Way
Eatontown,  NJ  07724 -3327
Applicant Contact AUDREY WITKO
Correspondent
Huntleigh Diagnostics , Ltd.
40 Christopher Way
Eatontown,  NJ  07724 -3327
Correspondent Contact AUDREY WITKO
Regulation Number884.2730
Classification Product Code
LQK  
Subsequent Product Code
MOH  
Date Received02/06/2002
Decision Date 04/19/2002
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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