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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 K940334
Device Name AMIGO J-9
Applicant
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Applicant Contact ANDREA J LUPO
Correspondent
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Correspondent Contact ANDREA J LUPO
Regulation Number890.3800
Classification Product Code
INI  
Date Received01/25/1994
Decision Date 05/18/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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