FDA 510(k) Application Details - K070999

Device Classification Name Analyzer, Body Composition

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510(K) Number K070999
Device Name Analyzer, Body Composition
Applicant RJL SYSTEMS, INC.
33939 HARPER AVE.
CLINTON TWP, MI 48035 US
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Contact BARRY CALLAHAN
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 04/09/2007
Decision Date 08/02/2007
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



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