FDA 510(k) Application Details - K170701

Device Classification Name Wheelchair, Mechanical

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510(K) Number K170701
Device Name Wheelchair, Mechanical
Applicant Free Wheelchair Mission
15279 Alton Parkway
Suite 300
Irvine, CA 92618 US
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Contact Don Schoendorfer
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 03/08/2017
Decision Date 03/24/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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