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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 K090479
Device Name TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
Applicant
Tanita Corporation of America
2625 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Applicant Contact TOSHIHIKO ISHIKAWA
Correspondent
Tanita Corporation of America
2625 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Correspondent Contact TOSHIHIKO ISHIKAWA
Regulation Number870.2770
Classification Product Code
MNW  
Date Received02/24/2009
Decision Date 07/07/2009
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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