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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 K023942
Device Name CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311
Applicant
YAMATO CORP.
518 17TH ST.
SUITE 1350
DENVER,  CO  80202
Applicant Contact CLAY ANSELMO
Correspondent
YAMATO CORP.
518 17TH ST.
SUITE 1350
DENVER,  CO  80202
Correspondent Contact CLAY ANSELMO
Regulation Number870.2770
Classification Product Code
MNW  
Date Received11/26/2002
Decision Date 02/24/2003
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
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