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FDA 510(k) Application Details - K101524
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K101524
Device Name
Wheelchair, Powered
Applicant
OTTO BOCK HEALTH CARE, LP
TWO CARLSON PARKWAY NORTH
SUITE 100
MINNEAPOLIS, MN 55447 US
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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
06/02/2010
Decision Date
09/29/2010
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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