FDA 510(k) Application Details - K230001

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K230001
Device Name Vehicle, Motorized 3-Wheeled
Applicant Guangdong Prestige Technology Co., Ltd.
No. 8, Road.1, 3rd Ind. District, Qiaotou Area, Houjie Town
Dongguan 523950 CN
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Contact Zhang Zhao
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 01/03/2023
Decision Date 07/05/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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