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FDA 510(k) Application Details - K023961
Device Classification Name
Wheelchair, Powered
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510(K) Number
K023961
Device Name
Wheelchair, Powered
Applicant
BURKE, INC.
1800 MERRIAM LN.
KANSAS CITY, KS 66106 US
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DUWAYNE E KRAMER JR.
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Regulation Number
890.3860
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Classification Product Code
ITI
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Date Received
11/29/2002
Decision Date
12/24/2002
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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