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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K113007
Device Name BIONIME DIABETES MANAGEMENT SYSTEM VI.0
Applicant
BIONIME CORPORATION
27001 LA PAZ RD.
SUITE 266B
MISSION VIEJO,  CA  92691
Applicant Contact Feng-Yu Lee
Correspondent
BIONIME CORPORATION
27001 LA PAZ RD.
SUITE 266B
MISSION VIEJO,  CA  92691
Correspondent Contact Feng-Yu Lee
Regulation Number862.2100
Classification Product Code
JQP  
Subsequent Product Code
NBW  
Date Received10/07/2011
Decision Date 02/27/2012
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
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