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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K896467
Device Name SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM
Applicant
Medisense, Inc.
128 Sidney St.
Cambridge,  MA  02139
Applicant Contact LIAS, PHD
Correspondent
Medisense, Inc.
128 Sidney St.
Cambridge,  MA  02139
Correspondent Contact LIAS, PHD
Regulation Number862.1175
Classification Product Code
CHH  
Date Received11/13/1989
Decision Date 06/12/1990
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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