FDA 510(k) Application Details - K031289

Device Classification Name Wheelchair, Powered

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510(K) Number K031289
Device Name Wheelchair, Powered
Applicant SUNRISE MEDICAL, INC.
7477 EAST DRY CREEK PKWY.
LONGMONT, CO 80503 US
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Contact MICHAEL CHELLSON
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 04/23/2003
Decision Date 05/09/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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