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FDA 510(k) Application Details - K000678
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K000678
Device Name
Wheelchair, Powered
Applicant
OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
3000 XENIUM LANE, SUITE N
PLYMOUTH, MN 55441 US
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Contact
WILLIAM JACKSON
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
02/29/2000
Decision Date
09/18/2000
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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