FDA 510(k) Application Details - K052646

Device Classification Name Analyzer, Body Composition

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510(K) Number K052646
Device Name Analyzer, Body Composition
Applicant BIOSPACE CORPORATION LIMITED
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 09/26/2005
Decision Date 12/16/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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