FDA 510(k) Application Details - K982144

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K982144
Device Name Vehicle, Motorized 3-Wheeled
Applicant MEGA MOTION, INC.
P.O. BOX 3744
SCRANTON, PA 18505 US
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Contact PAUL GRONKA
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 06/17/1998
Decision Date 04/14/1999
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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