FDA 510(k) Application Details - K080672

Device Classification Name System, Monitoring, For Progress Of Labor

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510(K) Number K080672
Device Name System, Monitoring, For Progress Of Labor
Applicant BARNEV, LTD.
20 HATA'AS ST.
KFAR SABA 44425 IL
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Contact AHAVA STEIN
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Regulation Number 884.2800

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Classification Product Code NPB
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Date Received 03/10/2008
Decision Date 07/08/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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