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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 K110395
Device Name C.T.M. MOBILITY SCOOTER - MODEL HS 118
Applicant
C.T.M. Homecare Product, Inc.
927 Throne Dr.
Eugene,  OR  97402
Applicant Contact SHEILA RAMERMAN
Correspondent
C.T.M. Homecare Product, Inc.
927 Throne Dr.
Eugene,  OR  97402
Correspondent Contact SHEILA RAMERMAN
Regulation Number890.3800
Classification Product Code
INI  
Date Received02/11/2011
Decision Date 04/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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