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FDA 510(k) Application Details - K013516
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K013516
Device Name
Wheelchair, Powered
Applicant
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA, OH 44036-2125 US
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Contact
RAE A FARROW
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
10/23/2001
Decision Date
12/13/2001
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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