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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K992684
Device Name FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Abbott Diabetes Care, Inc.
1360 S. Loop Dr.
Alameda,  CA  94502 -7000
Applicant Contact EVE A CONNER
Correspondent
Abbott Diabetes Care, Inc.
1360 S. Loop Dr.
Alameda,  CA  94502 -7000
Correspondent Contact EVE A CONNER
Regulation Number862.1345
Classification Product Code
LFR  
Date Received08/10/1999
Decision Date 01/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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