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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 K900738
Device Name BOOSTER MOTORIZED THREE WHEELED VEHICLE
Applicant
Burke Mobility Products
1800 Merriam Ln.
Kansas City,  KS  66106
Applicant Contact DUWAYNE E KRAMER
Correspondent
Burke Mobility Products
1800 Merriam Ln.
Kansas City,  KS  66106
Correspondent Contact DUWAYNE E KRAMER
Regulation Number890.3800
Classification Product Code
INI  
Date Received02/16/1990
Decision Date 02/22/1990
Decision Substantially Equivalent (SESE)
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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