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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wheelchair, special grade
510(K) Number K120302
Device Name MECHANICAL WHEELCHAIR
Applicant
NOVAF ANDALUCIA 2007, SL
camino se santa teresa
nave 1
rota, 
Contact fernando saenz de santamaria
Regulation Number890.3880
Classification Product Code
IQC  
Date Received02/01/2012
Decision Date 07/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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