FDA 510(k) Application Details - K080880

Device Classification Name Wheelchair, Mechanical

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510(K) Number K080880
Device Name Wheelchair, Mechanical
Applicant NEXT MOBILITY, LLC
543 LONG HILL AVENUE
SHELTON, CT 06484 US
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Contact JOSEPH AZARY
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 03/31/2008
Decision Date 04/09/2008
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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