FDA 510(k) Application Details - K080288

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K080288
Device Name Vehicle, Motorized 3-Wheeled
Applicant MEGA MOTION, INC.
957 WOOD ST.
OLD FORGE, PA 18518 US
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Contact TOM AMICO
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 02/04/2008
Decision Date 02/15/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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