FDA 510(k) Application Details - K130856

Device Classification Name Analyzer, Body Composition

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510(K) Number K130856
Device Name Analyzer, Body Composition
Applicant IPGDX, LLC
33 Golden Eagle Lane
Littleton, CO 80127 US
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Contact Kevin Walls
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 03/28/2013
Decision Date 11/25/2013
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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