FDA 510(k) Application Details - K971554

Device Classification Name Analyzer, Body Composition

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510(K) Number K971554
Device Name Analyzer, Body Composition
Applicant BODYSTAT LTD.
PO BOX 50
DOUGLAS ISLE OF MAN
BRITISH ISLES IM99 1DQ BR
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Contact L.J. MEEUWSEN
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 04/30/1997
Decision Date 11/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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