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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 K041881
Device Name ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
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 Codes
JJX   NBW  
Date Received07/12/2004
Decision Date 03/25/2005
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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