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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vein Location, Liquid Crystal
510(k) Number K152088
Device Name IV-eye
Applicant
Novarix Limited
The Core Business Centre, Milton Hill
Abingdon,  GB OX13 6AB
Applicant Contact JOHN SCOTT
Correspondent
Emergo Group
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact DEIRDRE BARROW
Regulation Number880.6970
Classification Product Code
KZA  
Date Received07/27/2015
Decision Date 02/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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