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FDA 510(k) Application Details - K011530
Device Classification Name
Wheelchair, Standup
More FDA Info for this Device
510(K) Number
K011530
Device Name
Wheelchair, Standup
Applicant
FENA DESIGN, INC.
PO BOX 560
STILLWATER, MN 55082 US
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Contact
ELAINE DUNCAN
Other 510(k) Applications for this Contact
Regulation Number
890.3900
More FDA Info for this Regulation Number
Classification Product Code
IPL
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More FDA Info for this Product Code
Date Received
05/17/2001
Decision Date
10/16/2001
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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