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FDA 510(k) Application Details - K192885
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K192885
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
Chien Ti Enterprise Co., Ltd.
No. 13, Lane 227, Fu Ying Rd
New Taipei City, Hsin Chuang District 24258 TW
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Contact
Vivian Lo
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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
10/10/2019
Decision Date
12/09/2019
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
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