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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 K841919
Device Name ALPHA TRI-KART
Applicant
ALPHA UNLIMITED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ALPHA UNLIMITED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/10/1984
Decision Date 05/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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