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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 K991658
Device Name PERMOBIL POWERED WHEELCHAIR 1280
Applicant
Permobil AB
Engelbrekts Vag 101
Sollentuna,  SE S-191 62
Applicant Contact BENGT PERSSON
Correspondent
Permobil AB
Engelbrekts Vag 101
Sollentuna,  SE S-191 62
Correspondent Contact BENGT PERSSON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/14/1999
Decision Date 10/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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