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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 K041193
Device Name A&I SCOOTER, SC-402
Applicant
Well Success Biotech, Inc.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
Well Success Biotech, Inc.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/06/2004
Decision Date 05/25/2004
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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