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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 K853733
Device Name MED-PEN/MED-POINT
Applicant
Garid, Inc.
10180 Viking Dr.
Eden Prairie,  MN  55344
Applicant Contact BERTRAM J HUDSON
Correspondent
Garid, Inc.
10180 Viking Dr.
Eden Prairie,  MN  55344
Correspondent Contact BERTRAM J HUDSON
Regulation Number862.1345
Classification Product Code
CGA  
Date Received09/06/1985
Decision Date 12/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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