FDA 510(k) Application Details - K983987

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K983987
Device Name Vehicle, Motorized 3-Wheeled
Applicant AMIGO MOBILITY INTL., INC.
6693 DIXIE HWY.
BRIDGEPORT, MI 48722 US
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Contact DALE CONFER
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 11/09/1998
Decision Date 06/08/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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