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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 K071884
Device Name BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
Applicant
JAWON MEDICAL CO., LTD.
#1208-12, Sinsang-Li, Jinryang-Myun
Kyungsan-city, Kyungsan-Bukdo,  KR 712-830
Applicant Contact Won-Hee Park
Correspondent
MI Consulting Co., Ltd.
ROOM 624, LIFE OFFICETEL, 61-3
YOIDO-DONG, YOUNGDEUNGPO-GU
SEOUL, KOREA,  KR 150-731
Correspondent Contact HL JUNG
Regulation Number870.2770
Classification Product Code
MNW  
Date Received07/09/2007
Decision Date 08/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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