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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 K963676
Device Name PRECISION G BLOOD GLUCOSE TESTING SYSTEM
Applicant
Medisense, Inc.
4a Crosby Dr.
Bedford,  MA  01730
Applicant Contact MICHAEL HALPIN
Correspondent
Medisense, Inc.
4a Crosby Dr.
Bedford,  MA  01730
Correspondent Contact MICHAEL HALPIN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received09/13/1996
Decision Date 02/20/1997
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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