FDA 510(k) Application Details - K120628

Device Classification Name Wheelchair, Mechanical

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510(K) Number K120628
Device Name Wheelchair, Mechanical
Applicant MOTION COMPOSITES
519 J-OSWALD-FOREST
SUITE 101
SAINT-ROCH-DE-L' ACHIGAN J063H0 CA
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Contact VINCENT LECUYER
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 03/01/2012
Decision Date 12/19/2012
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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