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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K162336
Device Name Contour Next EZ Blood Glucose Monitoring System
Applicant
Ascensia Diabetes Care US Inc.
430 South Beiger Street
Mishawaka,  IN  46544
Applicant Contact Jennifer L. Gregory
Correspondent
Ascensia Diabetes Care US Inc.
430 South Beiger Street
Mishawaka,  IN  46544
Correspondent Contact Jennifer L. Gregory
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received08/22/2016
Decision Date 01/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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