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FDA 510(k) Application Details - K231472
Device Classification Name
Vehicle, Motorized 3-Wheeled
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.3800
More FDA Info for this Regulation Number
Classification Product Code
INI
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More FDA Info for this Product Code
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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