FDA 510(k) Application Details - K032446

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K032446
Device Name Vehicle, Motorized 3-Wheeled
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact ANDREA HAFERKAMP
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 08/08/2003
Decision Date 02/12/2004
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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