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