FDA 510(k) Application Details - K023429

Device Classification Name Analyzer, Body Composition

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510(K) Number K023429
Device Name Analyzer, Body Composition
Applicant ROWENTA, INC.
196 BOSTON AVE.
MEDFORD, MA 02155 US
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Contact JONES STEVE
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 10/11/2002
Decision Date 09/23/2003
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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