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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 K061328
Device Name THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
Applicant
E-San Limited
2001 Pennsylvania Ave. NW
Suite 575
Washington,  DC  20006
Applicant Contact KRISTIN M ZIELINSKI
Correspondent
E-San Limited
2001 Pennsylvania Ave. NW
Suite 575
Washington,  DC  20006
Correspondent Contact KRISTIN M ZIELINSKI
Regulation Number862.1345
Classification Product Code
NBW  
Date Received05/12/2006
Decision Date 06/13/2006
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
Predetermined Change
Control Plan Authorized		 No
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