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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K143014
FOIA Releasable 510(k) K143014
Device Name F5
Applicant
Permobil AB
Per Uddens Vag 20
Timra,  SE 86123
Applicant Contact Jan Astrom
Correspondent
Permobil AB
Per Uddens Vag 20
Timra,  SE 86123
Correspondent Contact Jan Astrom
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/20/2014
Decision Date 03/25/2015
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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