FDA 510(k) Application Details - K040754

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K040754
Device Name Vehicle, Motorized 3-Wheeled
Applicant AMERICAN BANTEX CORP.
994 NORTH MAIN STREET
BOUNTIFUL, UT 84010 US
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Contact TRACY S BEST
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 03/24/2004
Decision Date 07/23/2004
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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