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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 K083099
Device Name EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
Applicant
Eps Bio Technology Corp.
2 F,# 49-2, Lane 2, Sec. 2,
Guang Fu Rd.
Hsinchu City,  TW 30071
Applicant Contact Y. C LEI
Correspondent
Eps Bio Technology Corp.
2 F,# 49-2, Lane 2, Sec. 2,
Guang Fu Rd.
Hsinchu City,  TW 30071
Correspondent Contact Y. C LEI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received10/20/2008
Decision Date 01/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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