FDA 510(k) Application Details - K012802

Device Classification Name Wheelchair, Powered

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510(K) Number K012802
Device Name Wheelchair, Powered
Applicant MERITS HEALTH PRODUCTS., INC.
P.O. BOX 150356
CAPE CORAL, FL 33915 US
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Contact WINSTON ANDERSON
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 08/21/2001
Decision Date 09/18/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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