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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 K020866
Device Name FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
alameda,  CA  94502 -7000
Applicant Contact donna k templeman
Correspondent
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
alameda,  CA  94502 -7000
Correspondent Contact donna k templeman
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/18/2002
Decision Date 06/11/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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