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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 K090712
Device Name EOCENE SYSTEM
Applicant
Infopia Co, Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
Infopia Co, Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received03/18/2009
Decision Date 10/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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