FDA 510(k) Application Details - K111636

Device Classification Name Wheelchair, Mechanical

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510(K) Number K111636
Device Name Wheelchair, Mechanical
Applicant GUNNELL, INC.
8440 STATE
P.O. BOX 308
MILLINGTON, MI 48746 US
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Contact ANDREW EVANCHO
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 06/13/2011
Decision Date 04/03/2012
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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