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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 K863468
Device Name EXACTECH(TM)
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact CARABILLO, JR
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact CARABILLO, JR
Regulation Number862.1345
Classification Product Code
CGA  
Date Received09/08/1986
Decision Date 12/08/1986
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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