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FDA 510(k) Application Details - K192647
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K192647
Device Name
Set, Administration, Intravascular
Applicant
Unomedical a/s
Aaholmvej 1-3
Osted DK-4320 DK
Other 510(k) Applications for this Company
Contact
Mette Busk Henningsen
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
09/24/2019
Decision Date
12/13/2019
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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