FDA 510(k) Application Details - K033819

Device Classification Name Wheelchair, Powered

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510(K) Number K033819
Device Name Wheelchair, Powered
Applicant INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA, OH 44035-4190 US
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Contact CARROLL MARTIN
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 12/09/2003
Decision Date 06/04/2004
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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