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FDA 510(k) Application Details - K130179
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K130179
Device Name
Set, I.V. Fluid Transfer
Applicant
MEDIMOP MEDICAL PROJECTS, LTD.
17 HATIDHAR ST.
RA'ANANA 4366519 IL
Other 510(k) Applications for this Company
Contact
ILANIT GOLDGRABER
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2013
Decision Date
08/08/2013
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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