FDA 510(k) Application Details - K103212

Device Classification Name Wheelchair, Mechanical

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510(K) Number K103212
Device Name Wheelchair, Mechanical
Applicant WHIRLWIND WHEELCHAIR INTERNATIONAL
1600 HOLLOWAY AVENUE
SCI 251
SAN FRANCISCO, CA 94132 US
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Contact MARC KRIZACK
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 11/01/2010
Decision Date 01/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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