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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 K143557
Device Name SupaScoota Motorized vehicle
Applicant
Eurogreen International, Inc.
#48, Ln.220, Sec.1, Fuzun Rd., Yuanlin Township
Changhua County,  TW 51055
Applicant Contact DAVID HSIEH
Correspondent
Eurogreen International, Inc.
#48, Ln.220, Sec.1, Fuzun Rd., Yuanlin Township
Changhua County,  TW 51055
Correspondent Contact DAVID HSIEH
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/15/2014
Decision Date 09/16/2015
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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