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FDA 510(k) Application Details - K061186
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K061186
Device Name
Wheelchair, Mechanical
Applicant
AERO INNOVATIVE RESEARCH, INC.
500 W. CLAY ST
VALLEY CENTER, KS 67147 US
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Contact
MATT COCHRAN
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
04/28/2006
Decision Date
05/12/2006
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
Y
Expedited Review
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