FDA 510(k) Application Details - K082857

Device Classification Name Wheelchair, Special Grade

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510(K) Number K082857
Device Name Wheelchair, Special Grade
Applicant ALPHA ONE
5600 WISCONSIN AVE
SUITE 509
CHEVY CHASE, MD 20815 US
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Contact PATSY J TRISLER
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Regulation Number 890.3880

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Classification Product Code IQC
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Date Received 09/29/2008
Decision Date 01/06/2009
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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