FDA 510(k) Application Details - K201286

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K201286
Device Name	Saline, Vascular Access Flush
Applicant	Nurse Assist, LLC 4409 Haltom Road Haltom City, TX 76117 US Other 510(k) Applications for this Company
Contact	Romeo Crisologo 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	05/14/2020
Decision Date	08/11/2020
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