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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 K030757
Device Name COACH 777-4
Applicant
Wheelchair & Scooter Express
4905 A. San Jacinto
Houston,  TX  77004
Applicant Contact CHRIS TINSLEY
Correspondent
Wheelchair & Scooter Express
4905 A. San Jacinto
Houston,  TX  77004
Correspondent Contact CHRIS TINSLEY
Regulation Number890.3800
Classification Product Code
INI  
Date Received03/11/2003
Decision Date 10/06/2003
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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