FDA 510(k) Application Details - K103771

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K103771
Device Name Vehicle, Motorized 3-Wheeled
Applicant LETRIX POWER HANGZHOU PTY LTD
10352 STANFORD RD
GARDEN GROVE, CA 92840 US
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Contact ROBERT DUNN
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 12/27/2010
Decision Date 05/06/2011
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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