FDA 510(k) Application Details - K213522

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K213522
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	Jane Gao 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	11/03/2021
Decision Date	03/22/2022
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