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FDA 510(k) Application Details - K070844
Device Classification Name
Pump, Infusion, Insulin
More FDA Info for this Device
510(K) Number
K070844
Device Name
Pump, Infusion, Insulin
Applicant
NILIMEDIX LTD.
31 HAAVODA ST.
BINYAMINA IL
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Contact
YORAM LEVY
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
LZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/27/2007
Decision Date
06/06/2008
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
N
Expedited Review
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