FDA 510(k) Application Details - K120526

Device Classification Name Wheelchair, Mechanical

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510(K) Number K120526
Device Name Wheelchair, Mechanical
Applicant JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
333 PFINGSTEN ROAD
NORTHBROOK, IL 60062 US
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Contact NED DEVINE
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 02/22/2012
Decision Date 03/08/2012
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 Y
Expedited Review



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