FDA 510(k) Application Details - K152088

Device Classification Name	Device, Vein Location, Liquid Crystal   More FDA Info for this Device
510(K) Number	K152088
Device Name	Device, Vein Location, Liquid Crystal
Applicant	Novarix Limited The Core Business Centre, Milton Hill Abingdon OX13 6AB GB Other 510(k) Applications for this Company
Contact	JOHN SCOTT Other 510(k) Applications for this Contact
Regulation Number	880.6970   More FDA Info for this Regulation Number
Classification Product Code	KZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2015
Decision Date	02/24/2016
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