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FDA 510(k) Application Details - DEN060006
Device Classification Name
System, Monitoring, For Progress Of Labor
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
884.2800
More FDA Info for this Regulation Number
Classification Product Code
NPB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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