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FDA 510(k) Application Details - K160503
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K160503
Device Name
Set, I.V. Fluid Transfer
Applicant
MEDIMOP MEDICAL PROJECTS LTD.
17 HATIDHAR ST.
RA'ANANA 4366519 IL
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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
02/24/2016
Decision Date
05/04/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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