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FDA 510(k) Application Details - K143557
Device Classification Name
Vehicle, Motorized 3-Wheeled
More FDA Info for this Device
510(K) Number
K143557
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
EUROGREEN INTERNATIONAL INC
NO.48, LN.220, SEC.1, FUZUN RD., YUANLIN TOWNSHIP
CHANGHUA COUNTY 51055 TW
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Contact
DAVID HSIEH
Other 510(k) Applications for this Contact
Regulation Number
890.3800
More FDA Info for this Regulation Number
Classification Product Code
INI
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More FDA Info for this Product Code
Date Received
12/15/2014
Decision Date
09/16/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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