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FDA 510(k) Application Details - K021371
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K021371
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
SUNPEX TECHNOLOGY CO., LTD.
676 CHUNG HSIAO ROAD
CHIA YI CITY TW
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Contact
JUDY HSU
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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
04/30/2002
Decision Date
05/16/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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