FDA 510(k) Application Details - K112149

Device Classification Name Analyzer, Body Composition

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510(K) Number K112149
Device Name Analyzer, Body Composition
Applicant SHINE OVERSEAS MARKETING LIMITED
77325 JOYCE WAY
ECHO, OR 97826 US
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Contact CHARLIE MACK
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 07/26/2011
Decision Date 04/09/2012
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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