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FDA 510(k) Application Details - K192190
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K192190
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
Dongguan Prestige Sporting Goods Co., Ltd
3rd Ind. District, Qiaotou Area, Houjie Town
Dongguan 523950 CN
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Contact
Zhang Zhao
Other 510(k) Applications for this Contact
Regulation Number
890.3800
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Classification Product Code
INI
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More FDA Info for this Product Code
Date Received
08/13/2019
Decision Date
04/23/2021
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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