FDA 510(k) Application Details - K952042

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K952042
Device Name Vehicle, Motorized 3-Wheeled
Applicant MERITS HEALTH PRODUCTS CO., LTD.
505 NORTH DEL PRADO
CAPE COPRAL, FL 33909 US
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Contact NANCY ANDERSON
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 05/01/1995
Decision Date 03/04/1996
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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