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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, body composition
510(k) Number K140045
Device Name BODY COMPOSITION ANALYZER
Applicant
JAWON MEDICAL CO., LTD.
#1208-12, Sinsang-Li, Jinryang-Myun
Kyungsan-city, Kyungsan-Bukdo,  KR 712-830
Applicant Contact W S PARK
Correspondent
MEDMONTS CO., LTD
LIFE-OFFICETEL 320,40,63-RO
YOUNGDEUNGPO-GU
SEOUL,  KR 150-731
Correspondent Contact W S PARK
Regulation Number870.2770
Classification Product Code
MNW  
Date Received01/08/2014
Decision Date 02/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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