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FDA 510(k) Application Details - K172884
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K172884
Device Name
Set, I.V. Fluid Transfer
Applicant
Yukon Medical
4021 Stirrup Creek Dr.
Suite #200
Durham, NC 27703 US
Other 510(k) Applications for this Company
Contact
Todd Korogi
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
09/21/2017
Decision Date
10/03/2017
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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