FDA 510(k) Application Details - K082900

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K082900
Device Name Vehicle, Motorized 3-Wheeled
Applicant KWANG YANG MOTOR CO., LTD.
14F-2, NO.1, ZHUANGJING ROAD
LANE 25
BANQIAO 220 TW
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Contact JUNNATA CHANG
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 09/30/2008
Decision Date 10/28/2008
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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