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FDA 510(k) Application Details - K051131
Device Classification Name
Vehicle, Motorized 3-Wheeled
More FDA Info for this Device
510(K) Number
K051131
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
NO. 17, 37TH RD.,
TAICHUNG INDUSTRY PARK
TAICHUNG 40768 TW
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Contact
CHANG WAN LAN
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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
05/03/2005
Decision Date
08/15/2005
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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