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FDA 510(k) Application Details - K982750
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K982750
Device Name
Wheelchair, Powered
Applicant
OPTIWAY, INC.
3000 K ST. N.W.
SUITE 500
WASHINGTON, DC 20007 US
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Contact
FRANK W LAVALLEY
Other 510(k) Applications for this Contact
Regulation Number
890.3860
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Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
08/06/1998
Decision Date
02/01/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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