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FDA 510(k) Application Details - K071741
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K071741
Device Name
Set, I.V. Fluid Transfer
Applicant
MIGADA PLANT
NORTH INDUSTRIAL ZONE
KIRYAT SHMONA 10258 IL
Other 510(k) Applications for this Company
Contact
YOSSI SHACHAR
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
06/27/2007
Decision Date
09/24/2007
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
N
Expedited Review
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