FDA 510(k) Application Details - K153481

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K153481
Device Name	Saline, Vascular Access Flush
Applicant	BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE FRANKLIN LAKES, NJ 07417 US Other 510(k) Applications for this Company
Contact	John Blewitt 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	12/03/2015
Decision Date	04/04/2016
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