FDA 510(k) Application Details - K230992

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K230992
Device Name	Set, Administration, Intravascular
Applicant	Yangzhou Wei De Li Trade Co. Ltd Room 2412, Bldg.5, Cai Fu Plaza, 287 Yangzijiang Middle Road Yangzhou 225000 CN Other 510(k) Applications for this Company
Contact	Joyce Wu 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	04/06/2023
Decision Date	06/09/2023
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