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FDA 510(k) Application Details - K113713
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K113713
Device Name
Wheelchair, Mechanical
Applicant
FREE WHEELCHAIR MISSION
5582 CHALON ROAD
YORBA LINDA, CA 92886 US
Other 510(k) Applications for this Company
Contact
SHARON ROCKWELL
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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