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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
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