FDA 510(k) Application Details - K092431

Device Classification Name Analyzer, Body Composition

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510(K) Number K092431
Device Name Analyzer, Body Composition
Applicant JAWON MEDICAL CO., LTD.
#1208-12, Sinsang-Li, Jinryang-Myun
Kyungsan-city, Kyungsan-Bukdo 712-830 KR
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Contact Won-Hee Park
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 08/07/2009
Decision Date 10/08/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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