FDA 510(k) Application Details - K140023

Device Classification Name Wheelchair, Mechanical

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510(K) Number K140023
Device Name Wheelchair, Mechanical
Applicant PDG PRODUCT DESIGN GROUP, INC.
5905 FAWN LANE
CLEVELAND, OH 44141 US
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Contact EDWARD A KROLL
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 01/06/2014
Decision Date 10/16/2014
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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