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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K031843
Device Name MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060 -4486
Applicant Contact ANDREA HAFERKAMP
Correspondent
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060 -4486
Correspondent Contact ANDREA HAFERKAMP
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received06/16/2003
Decision Date 07/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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