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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,  ES PC 11520
Applicant Contact FERNANDO SAENZ DE SANTAMARIA
Correspondent
Novaf Andalucia 2007, SL
Camino SE Santa Teresa
Nave 1
Rota,  ES PC 11520
Correspondent Contact FERNANDO SAENZ DE SANTAMARIA
Regulation Number890.3880
Classification Product Code
IQC  
Date Received02/01/2012
Decision Date 07/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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