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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 K122370
Device Name CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
Applicant
BAYER HEALTHCARE
430 SOUTH BEIGER STREET
MISHAWAKA,  IN  46544
Applicant Contact ROGER SONNENBURG
Correspondent
BAYER HEALTHCARE
430 SOUTH BEIGER STREET
MISHAWAKA,  IN  46544
Correspondent Contact ROGER SONNENBURG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received08/06/2012
Decision Date 09/26/2013
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
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