FDA 510(k) Application Details - K183473

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K183473
Device Name	Saline, Vascular Access Flush
Applicant	Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768 US Other 510(k) Applications for this Company
Contact	Jim Barley 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	12/14/2018
Decision Date	07/12/2019
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