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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 K022698
Device Name SCOOTER MARS SERIES, MODEL TL-588
Applicant
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
NO. 58, FU-CHIUN ST.
HSIN CHU CITY,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
NO. 58, FU-CHIUN ST.
HSIN CHU CITY,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/13/2002
Decision Date 12/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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