FDA 510(k) Application Details - K163591

Device Classification Name	Heparin, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K163591
Device Name	Heparin, Vascular Access Flush
Applicant	Becton Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07045 US Other 510(k) Applications for this Company
Contact	Aakash Jain Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2016
Decision Date	02/27/2017
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