FDA 510(k) Application Details - K130311

Device Classification Name Analyzer, Body Composition

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510(K) Number K130311
Device Name Analyzer, Body Composition
Applicant GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
NO.1 FANGHUA STREET, HI-TECH DISTRICT
CHENGDU 610041 CN
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Contact LEO WANG
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 02/08/2013
Decision Date 05/30/2013
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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