FDA 510(k) Application Details - K061810

Device Classification Name Wheelchair, Mechanical

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510(K) Number K061810
Device Name Wheelchair, Mechanical
Applicant R82 A/S
12801 EAST INDEPENDENCE BLVD.
STALLINGS, NC 28105 US
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Contact KIRK MACKENZIE
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 06/27/2006
Decision Date 08/07/2006
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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