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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 K033019
Device Name SUNPEX TECHNOLOGIES MODEL SE03
Applicant
Sunpex Technology Co., Ltd.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Applicant Contact LEONARD FRIER
Correspondent
Sunpex Technology Co., Ltd.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Correspondent Contact LEONARD FRIER
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/26/2003
Decision Date 01/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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