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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 K101507
Device Name AMIGO CLASSIC FD
Applicant
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Applicant Contact MIKE LABRAKE
Correspondent
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Correspondent Contact MIKE LABRAKE
Regulation Number890.3800
Classification Product Code
INI  
Date Received06/01/2010
Decision Date 07/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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