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FDA 510(k) Application Details - K041219
Device Classification Name
Wheelchair, Powered
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510(K) Number
K041219
Device Name
Wheelchair, Powered
Applicant
PERMOBIL A.B.
BOX 120
TIMRA S-861 23 SE
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Contact
JAN' ASTROM
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
05/10/2004
Decision Date
08/04/2004
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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