FDA 510(k) Application Details - K242628

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K242628
Device Name Vehicle, Motorized 3-Wheeled
Applicant Lichtmega Technology Co., Ltd.
#101, No. 200, Cangjing Road, Songjiang District
Shanghai CN
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Contact Hyman Zhu
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 09/03/2024
Decision Date 12/20/2024
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 K242628


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