FDA 510(k) Application Details - K131302

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K131302
Device Name Vehicle, Motorized 3-Wheeled
Applicant DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
16F-2(16A), NO. 462, SEC. 2 CHONGDE RD.
BEITUN DIST.
TAICHUNG 406 TW
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Contact JUNNATA CHANG
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 05/07/2013
Decision Date 11/26/2013
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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