FDA 510(k) Application Details - K081984

Device Classification Name System, Monitoring, For Progress Of Labor

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510(K) Number K081984
Device Name System, Monitoring, For Progress Of Labor
Applicant TRIG MEDICAL LTD
7 JABOTINSKY STREET
MOSHE AVIV BUILDING
RAMAT-GAN 52520 IL
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Contact KEREN SHTIEGMAN
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Regulation Number 884.2800

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Classification Product Code NPB
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Date Received 07/11/2008
Decision Date 03/04/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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