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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 K072369
Device Name EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
Applicant
HMD BIOMEDICAL LLC
8855 GRISSOM PARKWAY
TITUSVILLE,  FL  32780
Applicant Contact MERRELL SHYE
Correspondent
HMD BIOMEDICAL LLC
8855 GRISSOM PARKWAY
TITUSVILLE,  FL  32780
Correspondent Contact MERRELL SHYE
Regulation Number862.1345
Classification Product Code
NBW  
Date Received08/23/2007
Decision Date 03/21/2008
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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