FDA 510(k) Application Details - K022924

Device Classification Name Wheelchair, Mechanical

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510(K) Number K022924
Device Name Wheelchair, Mechanical
Applicant OTTO BACK HEALTHCARE, LP
2 CARLSON PARKWAY N.
SUITE 100
MINNEAPOLIS, MN 55447-4467 US
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Contact E.P. (BERT) HARMAN
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 09/04/2002
Decision Date 10/17/2002
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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