FDA 510(k) Application Details - K120302

Device Classification Name Wheelchair, Special Grade

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510(K) Number K120302
Device Name Wheelchair, Special Grade
Applicant NOVAF ANDALUCIA 2007, SL
CAMINO SE SANTA TERESA
NAVE 1
ROTA PC 11520 ES
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Contact FERNANDO SAENZ DE SANTAMARIA
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Regulation Number 890.3880

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Classification Product Code IQC
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Date Received 02/01/2012
Decision Date 07/06/2012
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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