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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K942508
Device Name ROBO
Applicant
Permobil AB
Box 120 S-861 23
Timra,  SE
Applicant Contact BENGT PERSSON
Correspondent
Permobil AB
Box 120 S-861 23
Timra,  SE
Correspondent Contact BENGT PERSSON
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/26/1994
Decision Date 11/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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