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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 K081980
Device Name KYMCO FORU, MODEL EQ35
Applicant
Besteam Technology, Inc.
14f-2, #1, Ln. 25
Zhuangjing Rd.
Banqiao,  TW 220
Applicant Contact JUNNATA CHANG
Correspondent
Besteam Technology, Inc.
14f-2, #1, Ln. 25
Zhuangjing Rd.
Banqiao,  TW 220
Correspondent Contact JUNNATA CHANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received07/11/2008
Decision Date 08/04/2008
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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