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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 K960337
Device Name AMD HOME HEALTH MONITORING SYSTEM
Applicant
Advanced Medical Devices, Inc.
152 W. Wisconsin Ave.
Suite 930
Milwaukee,  WI  53203
Applicant Contact BRIAN W PETERSEN
Correspondent
Advanced Medical Devices, Inc.
152 W. Wisconsin Ave.
Suite 930
Milwaukee,  WI  53203
Correspondent Contact BRIAN W PETERSEN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received01/24/1996
Decision Date 09/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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