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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K031388
Device Name MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Hypoguard USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact BRUCE A MACFARLANE
Correspondent
Hypoguard USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact BRUCE A MACFARLANE
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received05/02/2003
Decision Date 05/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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