FDA 510(k) Application Details - DEN060006

Device Classification Name System, Monitoring, For Progress Of Labor

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510(K) Number DEN060006
Device Name System, Monitoring, For Progress Of Labor
Applicant BARNEV, LTD.
20 HATA'AS ST.
BEIT HAPA'AMON (BOX 124)
KFAR SABA 44425 IL
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Contact ARAVA HACOHEN
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Regulation Number 884.2800

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Classification Product Code NPB
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Date Received 10/18/2006
Decision Date 01/30/2007
Decision DENG -
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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