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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 K060068
Device Name AVANTICARE, MODEL SA4021
Applicant
Lerado China Limited
Chongde Rd., Beitun District
Taichung,  TW 40653
Applicant Contact JEFF CHANG
Correspondent
Lerado China Limited
Chongde Rd., Beitun District
Taichung,  TW 40653
Correspondent Contact JEFF CHANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received01/09/2006
Decision Date 03/08/2006
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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