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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 K042104
Device Name AMERICAN BANTEX, MODEL MS 3
Applicant
AMERICAN BANTEX CORP.
994 NORTH MAIN STREET
BOUNTIFUL,  UT  84010
Applicant Contact TRACY S BEST
Correspondent
AMERICAN BANTEX CORP.
994 NORTH MAIN STREET
BOUNTIFUL,  UT  84010
Correspondent Contact TRACY S BEST
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/04/2004
Decision Date 10/21/2004
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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