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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 A.B.
ENGELBREKTS VAG 101
SOLLENTUNA,  SE S-191 62
Applicant Contact BENGT PERSSON
Correspondent
PERMOBIL A.B.
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
Recalls CDRH Recalls
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