FDA 510(k) Application Details - K192414

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K192414
Device Name	Saline, Vascular Access Flush
Applicant	MedXL Inc. 285 Av Labrosse Pointe-Claire H9R 1A3 CA Other 510(k) Applications for this Company
Contact	Premala Premanathan Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2019
Decision Date	02/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review