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FDA 510(k) Application Details - K070529
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K070529
Device Name
Pump, Infusion
Applicant
DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
4 HAMELACHA ST.
NORTH INDUSTRIAL ZONE
LOD 71520 IL
Other 510(k) Applications for this Company
Contact
BOAZ BARTOV
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
02/23/2007
Decision Date
05/08/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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