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FDA 510(k) Application Details - K151963
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K151963
Device Name
Set, I.V. Fluid Transfer
Applicant
YUKON MEDICAL, LLC
4021 STIRRUP CREEK DRIVE
SUITE200
DURHAM, NC 27703 US
Other 510(k) Applications for this Company
Contact
CARL DUPPER
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
07/16/2015
Decision Date
07/31/2015
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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