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FDA 510(k) Application Details - K173879
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K173879
Device Name
Set, Administration, Intravascular
Applicant
Unomedical A/S
Aaholmvej 1-3
Osted DK-4320 DK
Other 510(k) Applications for this Company
Contact
Heidi Bjerre Lovkvist
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2017
Decision Date
03/05/2018
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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