FDA 510(k) Application Details - K050345

Device Classification Name Wheelchair, Mechanical

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510(K) Number K050345
Device Name Wheelchair, Mechanical
Applicant CARLSBAD INTERNATIONAL EXPORT, INC.
1954 KELLOGG AVE.
CARLSBAD, CA 92008 US
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Contact LAURA MEYER
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 02/11/2005
Decision Date 03/29/2005
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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