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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 K971554
Device Name BODYSTAT
Applicant
Bodystat , Ltd.
P.O. Box 50
Douglas Isle Of Man
British Isles,  BR IM99 1DQ
Applicant Contact L.J. MEEUWSEN
Correspondent
Bodystat , Ltd.
P.O. Box 50
Douglas Isle Of Man
British Isles,  BR IM99 1DQ
Correspondent Contact L.J. MEEUWSEN
Regulation Number870.2770
Classification Product Code
MNW  
Date Received04/30/1997
Decision Date 11/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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