FDA 510(k) Application Details - K953427

Device Classification Name Wheelchair, Mechanical

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510(K) Number K953427
Device Name Wheelchair, Mechanical
Applicant KUSCHALL OF AMERICA
708 VIA ALONDRA
CAMARILLO, CA US
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Contact THOMAS A VACHET
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 07/21/1995
Decision Date 07/31/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee NE - Neurology
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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