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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 K101457
Device Name EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
Applicant
Eps Bio Technology Corp.
#8 R&D Rd. Iii
Hsinchu Science Park
Hsinchu City, Hsinchu,  TW 300
Applicant Contact Y.C. LEI
Correspondent
Eps Bio Technology Corp.
#8 R&D Rd. Iii
Hsinchu Science Park
Hsinchu City, Hsinchu,  TW 300
Correspondent Contact Y.C. LEI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received05/26/2010
Decision Date 07/01/2010
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
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