FDA 510(k) Application Details - K040561

Device Classification Name Wheelchair, Mechanical

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510(K) Number K040561
Device Name Wheelchair, Mechanical
Applicant SHANGHAI WHEELCHAIR FACTORY
120 IONIA STREET SW
SUITE 102
GRAND RAPIDS, MI 49503 US
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Contact TRACY MA
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 03/03/2004
Decision Date 03/31/2004
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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