FDA 510(k) Application Details - K113713

Device Classification Name Wheelchair, Mechanical

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510(K) Number K113713
Device Name Wheelchair, Mechanical
Applicant FREE WHEELCHAIR MISSION
5582 CHALON ROAD
YORBA LINDA, CA 92886 US
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Contact SHARON ROCKWELL
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 12/19/2011
Decision Date 05/07/2012
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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