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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, For Progress Of Labor
510(k) Number K081984
Device Name LABORPRO SYSTEM
Applicant
TRIG MEDICAL LTD
7 JABOTINSKY STREET
MOSHE AVIV BUILDING
RAMAT-GAN,  IL 52520
Applicant Contact KEREN SHTIEGMAN
Correspondent
TRIG MEDICAL LTD
7 JABOTINSKY STREET
MOSHE AVIV BUILDING
RAMAT-GAN,  IL 52520
Correspondent Contact KEREN SHTIEGMAN
Regulation Number884.2800
Classification Product Code
NPB  
Date Received07/11/2008
Decision Date 03/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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