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FDA 510(k) Application Details - K970543
Device Classification Name
Wheelchair, Standup
More FDA Info for this Device
510(K) Number
K970543
Device Name
Wheelchair, Standup
Applicant
QUEST ENABLING DESIGNS LTD.
ABILITY HOUSE, 242 GOSPORT RD
FAREHAM, HAMPSHIRE PO 16 OSS GB
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Contact
NAHEED AKHTAR
Other 510(k) Applications for this Contact
Regulation Number
890.3900
More FDA Info for this Regulation Number
Classification Product Code
IPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/1997
Decision Date
06/26/1997
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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