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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 K123290
Device Name M300 & M400
Applicant
PERMOBIL AB
PER UDDENS VAG 20
TIMRA,  SE S-861 23
Applicant Contact JAN ASTROM
Correspondent
PERMOBIL AB
PER UDDENS VAG 20
TIMRA,  SE S-861 23
Correspondent Contact JAN ASTROM
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/22/2012
Decision Date 04/17/2013
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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