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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 K040754
Device Name AMERICAN BANTEX MS 4 MINI SCOOTER
Applicant
American Bantex Corp.
994 N. Main St.
Bountiful,  UT  84010
Applicant Contact TRACY S BEST
Correspondent
American Bantex Corp.
994 N. Main St.
Bountiful,  UT  84010
Correspondent Contact TRACY S BEST
Regulation Number890.3800
Classification Product Code
INI  
Date Received03/24/2004
Decision Date 07/23/2004
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
Predetermined Change
Control Plan Authorized		 No
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