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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 K120708
Device Name ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Cilag GmbH International
1000 Gibraltar Dr.
Milpitas,  CA  95035
Applicant Contact NADINE NASR
Correspondent
Cilag GmbH International
1000 Gibraltar Dr.
Milpitas,  CA  95035
Correspondent Contact NADINE NASR
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received03/08/2012
Decision Date 02/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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