FDA 510(k) Application Details - K050507

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K050507
Device Name Vehicle, Motorized 3-Wheeled
Applicant CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
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

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Classification Product Code INI
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Date Received 02/28/2005
Decision Date 07/07/2005
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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