FDA 510(k) Application Details - K053574

Device Classification Name Wheelchair, Mechanical

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510(K) Number K053574
Device Name Wheelchair, Mechanical
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact LARA N SIMMONS
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 12/22/2005
Decision Date 01/25/2006
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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