FDA 510(k) Application Details - K962565

Device Classification Name Wheelchair, Powered

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510(K) Number K962565
Device Name Wheelchair, Powered
Applicant ORTHOFAB, INC.
2160, RUE DE CELLES
QUEBEC CITY, QUEBEC G2C 1X8 CA
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Contact RICHARD LAPIERRE
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 07/01/1996
Decision Date 03/20/1997
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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