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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 K063162
Device Name GOLDEN LITEWAY
Applicant
Golden Technologies, Inc.
401 Bridge St.
Old Forge,  PA  18518
Applicant Contact GENE R KULON
Correspondent
Golden Technologies, Inc.
401 Bridge St.
Old Forge,  PA  18518
Correspondent Contact GENE R KULON
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/18/2006
Decision Date 11/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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