FDA 510(k) Application Details - K210544

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K210544
Device Name	Set, Administration, Intravascular
Applicant	Unomedical A/S Aaholmvej 1-3 Osted 4320 DK Other 510(k) Applications for this Company
Contact	Lone Sylvest Vestergaard Jepsen 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	02/24/2021
Decision Date	07/16/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review