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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 K052646
Device Name BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
Applicant
BIOSPACE CORPORATION LIMITED
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
BIOSPACE CORPORATION LIMITED
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/26/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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