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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K103172
Device Name CIV-OB (PLUS)
Applicant
CIVNET COMMUNICATION LTD
Hatamar 58
Moshav Hemed,  IL 50295
Applicant Contact NATHAN BEN-NATHAN
Correspondent
CIVNET COMMUNICATION LTD
Hatamar 58
Moshav Hemed,  IL 50295
Correspondent Contact NATHAN BEN-NATHAN
Regulation Number884.2740
Classification Product Code
HGM  
Date Received10/28/2010
Decision Date 03/11/2011
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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