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FDA 510(k) Application Details - K954427
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K954427
Device Name
Wheelchair, Powered
Applicant
KINETIC REHABILITATION INSTRUMENTS, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON, DC 20005 US
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Contact
TERRY G MAHN
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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
09/22/1995
Decision Date
09/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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