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FDA 510(k) Application Details - K053556
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K053556
Device Name
Analyzer, Body Composition
Applicant
JAWON MEDICAL CO., LTD.
ROOM 624, LIFE OFFICETEL, 61-3
YOIDO-DONG, YOUNGDEUNGPO-GU
SEOUL, KOREA 150-731 KR
Other 510(k) Applications for this Company
Contact
HEUNG BONG LIM
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
12/20/2005
Decision Date
08/31/2006
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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