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FDA 510(k) Application Details - K031749
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K031749
Device Name
Pump, Infusion
Applicant
CAESAREA MEDICAL ELECTRONICS LTD.
16 SHACHAM STREET
CAESAREA INDUSTRIAL PARK
CAESAREA 38900 IL
Other 510(k) Applications for this Company
Contact
GALI TZURY
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/05/2003
Decision Date
08/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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