FDA 510(k) Application Details - K231472

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K231472
Device Name Vehicle, Motorized 3-Wheeled
Applicant Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
No. 68 Xinfa Road, Suzhou Industrial Park
Suzhou 215000 CN
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Contact Ryan Chen
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 05/22/2023
Decision Date 07/19/2023
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 K231472


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