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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
TIMRA,  SE S-861 23
Applicant Contact JAN ASTROM
Correspondent
PERMOBIL AB
BOX 120
TIMRA,  SE S-861 23
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
Recalls CDRH Recalls
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