FDA 510(k) Application Details - K173360

Device Classification Name Wheelchair, Mechanical

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510(K) Number K173360
Device Name Wheelchair, Mechanical
Applicant Medical Rehab Products, LLC
PO BOX 1182
Montreat, NC 28757 US
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Contact Brad Evans
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 10/26/2017
Decision Date 05/17/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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