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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 K150942
Device Name Contour Next USB Blood Glucose Monitoring System
Applicant
BAYER HEALTHCARE
DIABETES CARE
430 SOUTH BEIGER STREET
MISHAWAKA,  IN  46544
Applicant Contact JENNIFER L. GREGORY
Correspondent
BAYER HEALTHCARE
430 South Beiger St.
MISHAWAKA,  IN  46544
Correspondent Contact JENNIFER L. GREGORY
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received04/08/2015
Decision Date 11/25/2015
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
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