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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 K910573
Device Name GLUCOSE V
Applicant
Caro Med, Inc.
715 Buckeye Ter.
Rock Hill,  SC  29730
Applicant Contact CHARLES F NEILSON
Correspondent
Caro Med, Inc.
715 Buckeye Ter.
Rock Hill,  SC  29730
Correspondent Contact CHARLES F NEILSON
Regulation Number862.1345
Classification Product Code
CGA  
Date Received02/11/1991
Decision Date 04/03/1991
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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