FDA 510(k) Application Details - K021925

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K021925
Device Name Vehicle, Motorized 3-Wheeled
Applicant SUNPEX TECHNOLOGY CO., LTD.
914 WEST PATAPSCO AVE.
BALTIMORE, MD 21230 US
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Contact LEONARD FRIER
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 06/11/2002
Decision Date 11/08/2002
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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