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FDA 510(k) Application Details - K140045
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K140045
Device Name
Analyzer, Body Composition
Applicant
JAWON MEDICAL CO., LTD.
#1208-12, Sinsang-Li, Jinryang-Myun
Kyungsan-city, Kyungsan-Bukdo 712-830 KR
Other 510(k) Applications for this Company
Contact
W S PARK
Other 510(k) Applications for this Contact
Regulation Number
870.2770
More FDA Info for this Regulation Number
Classification Product Code
MNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/08/2014
Decision Date
02/18/2015
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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