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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 K052522
Device Name STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
Applicant
Stayhealthy, Inc.
300 Elfwood Dr.
Monrovia,  CA  91016
Applicant Contact COLIN K HILL
Correspondent
Stayhealthy, Inc.
300 Elfwood Dr.
Monrovia,  CA  91016
Correspondent Contact COLIN K HILL
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/14/2005
Decision Date 12/13/2005
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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