FDA 510(k) Application Details - K970575

Device Classification Name Wheelchair, Powered

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510(K) Number K970575
Device Name Wheelchair, Powered
Applicant DAMACO
5105 MAUREEN LN.
MOORPARK, CA 93021 US
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Contact RON HIGGINBOTHAM
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/13/1997
Decision Date 08/05/1997
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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