FDA 510(k) Application Details - K123290

Device Classification Name Wheelchair, Powered

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510(K) Number K123290
Device Name Wheelchair, Powered
Applicant PERMOBIL AB
PER UDDENS VAG 20
TIMRA S-861 23 SE
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Contact JAN ASTROM
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 10/22/2012
Decision Date 04/17/2013
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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