FDA 510(k) Application Details - K120405

Device Classification Name Wheelchair, Powered

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510(K) Number K120405
Device Name Wheelchair, Powered
Applicant WALK ON WHEELS AUSTRALIA PTY LTD
927 THRONE DR.
EUGENE, OR 97402 US
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Contact SHEILA RAMERMAN
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/09/2012
Decision Date 09/19/2012
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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