FDA 510(k) Application Details - K100350

Device Classification Name Wheelchair, Powered

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510(K) Number K100350
Device Name Wheelchair, Powered
Applicant HOVEROUND CORP.
2151 WHITFIELD INDUSTRIAL WAY
SARASOTA, FL 34243 US
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Contact TONY GIOVANNI
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/12/2010
Decision Date 03/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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