FDA 510(k) Application Details - K052486

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K052486
Device Name Vehicle, Motorized 3-Wheeled
Applicant PROASIA LIMITED
16F-2, NO. 462 CHONG-DE ROAD
SEC. 2
BEITUN DISTRICT, TAICHUNG 40653 TW
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Contact JEFF CHANG
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 09/09/2005
Decision Date 10/07/2005
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

FDA Source Information for K052486


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