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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 K032919
Device Name C.T.M. MOBILITY SCOOTER, MODEL HS-250
Applicant
C.T.M. Homecare Product, Inc.
3636 E Columbine Dr.
Phoenix,  AZ  85032
Applicant Contact ROBERT S MCQUATE
Correspondent
C.T.M. Homecare Product, Inc.
3636 E Columbine Dr.
Phoenix,  AZ  85032
Correspondent Contact ROBERT S MCQUATE
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/22/2003
Decision Date 10/15/2003
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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