FDA 510(k) Application Details - K123975

Device Classification Name Wheelchair, Mechanical

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510(K) Number K123975
Device Name Wheelchair, Mechanical
Applicant SUNRISE MEDICAL
2842 BUSINESS PARK AVE.
FRESNO, CA 93727-1328 US
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Contact LAURIE ROBERTS
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 12/26/2012
Decision Date 08/16/2013
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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