FDA 510(k) Application Details - K113164

Device Classification Name Wheelchair, Mechanical

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510(K) Number K113164
Device Name Wheelchair, Mechanical
Applicant OTTO BOCK HEALTHCARE, LP
2 CARLSON PKWY. N., SUITE 100
MINNEAPOLIS, MN 55447 US
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Contact WILLIAM KABITZ
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 10/26/2011
Decision Date 03/11/2013
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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