FDA 510(k) Application Details - K021145

Device Classification Name Wheelchair, Mechanical

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510(K) Number K021145
Device Name Wheelchair, Mechanical
Applicant MARKEN INTERNATIONAL, INC.
851 BRIDGER STR.
SUITE 1
BOZEMAN, MT 59715 US
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Contact STEVE RIFFEL
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 04/09/2002
Decision Date 05/16/2002
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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