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FDA 510(k) Application Details - K111278
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K111278
Device Name
Wheelchair, Powered
Applicant
OTTO BOCK HEALTHCARE, LP
TWO CARLSON PARKWAY NORTH
SUITE 100
MINNEAPOLIS, MN 55447-4467 US
Other 510(k) Applications for this Company
Contact
WILLIAM KABITZ
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2011
Decision Date
09/16/2011
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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