FDA 510(k) Application Details - K033125

Device Classification Name Wheelchair, Mechanical

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510(K) Number K033125
Device Name Wheelchair, Mechanical
Applicant HANDINOR USA, INC.
17610 26TH AVE. NORTH
PLYMOUTH, MN 55447 US
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Contact BARBARA CHIPONIS
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 09/30/2003
Decision Date 10/30/2003
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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