FDA 510(k) Application Details - K082253

Device Classification Name Analyzer, Body Composition

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510(K) Number K082253
Device Name Analyzer, Body Composition
Applicant BODYSTAT LTD.
PO BOX 50
DOUGLAS ISLE OF MAN
BRITISH ISLES IM99 1DQ GB
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Contact I. J. MEEUWSEN
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 08/08/2008
Decision Date 11/25/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K082253


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