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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 K021371
Device Name SUNSPEX TECHNOLOGIES MODEL SE 02
Applicant
Sunpex Technology Co., Ltd.
676 Chung Hsiao Rd.
Chia Yi City,  TW
Applicant Contact JUDY HSU
Correspondent
Sunpex Technology Co., Ltd.
676 Chung Hsiao Rd.
Chia Yi City,  TW
Correspondent Contact JUDY HSU
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/30/2002
Decision Date 05/16/2002
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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