FDA 510(k) Application Details - K973473

Device Classification Name Wheelchair, Mechanical

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510(K) Number K973473
Device Name Wheelchair, Mechanical
Applicant TEXIN INDUSTRIAL (INTERNATIONAL) LTD.
169-8623 GRANVILLE ST.
VANCOUVER, BC V6P 5A1 CA
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Contact BILL LAM
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 09/15/1997
Decision Date 09/26/1997
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 Y
Expedited Review



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