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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 K071650
Device Name C350 POWERED WHEELCHAIR
Applicant
Permobil AB
Box 120 S-861 23
Timra,  SE
Applicant Contact JAN ASTROM
Correspondent
Permobil AB
Box 120 S-861 23
Timra,  SE
Correspondent Contact JAN ASTROM
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/18/2007
Decision Date 09/12/2007
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
Recalls CDRH Recalls
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