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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 K915416
Device Name FYMCO FLYER
Applicant
Motion Dynamics
110 Cidermill Ave.
Bldg. C-North
Concord, Ontario Canada,  CA L4K 2L9
Applicant Contact BLAINE HOBSON
Correspondent
Motion Dynamics
110 Cidermill Ave.
Bldg. C-North
Concord, Ontario Canada,  CA L4K 2L9
Correspondent Contact BLAINE HOBSON
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/02/1991
Decision Date 08/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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