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FDA 510(k) Application Details - K032765
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K032765
Device Name
Wheelchair, Powered
Applicant
PERMOBIL A.B.
ARVALTSV. 10, BOX 120
TIMRA S-861 00 SE
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Contact
BENGT PERSSON
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/2003
Decision Date
01/30/2004
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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