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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Body Composition
510(k) Number K023817
Device Name SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
Applicant
Clio Designs, Inc.
One Grove St.
Watertown,  MA  02472
Applicant Contact BERNARD FABRICANT
Correspondent
Clio Designs, Inc.
One Grove St.
Watertown,  MA  02472
Correspondent Contact BERNARD FABRICANT
Regulation Number870.2770
Classification Product Code
MNW  
Date Received11/15/2002
Decision Date 06/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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