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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 K121087
Device Name CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
Applicant
BAYER HEALTHCARE
430 SOUTH BEIGER ST.
MISHAWAKA,  IN  46544
Applicant Contact ROGER SONNENBURG
Correspondent
BAYER HEALTHCARE
430 SOUTH BEIGER ST.
MISHAWAKA,  IN  46544
Correspondent Contact ROGER SONNENBURG
Regulation Number862.1345
Classification Product Code
NBW  
Date Received04/10/2012
Decision Date 06/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Clinical Trials NCT01466075
Reviewed by Third Party No
Combination Product No
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