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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 K090735
Device Name C.T.M. MOBILITY SCOOTER, HS-528
Applicant
C.T.M. HOMECARE PRODUCT, INC.
29611 SIMMONS ROAD
EUGENE,  OR  97405
Applicant Contact LINDA J BOVARD
Correspondent
C.T.M. HOMECARE PRODUCT, INC.
29611 SIMMONS ROAD
EUGENE,  OR  97405
Correspondent Contact LINDA J BOVARD
Regulation Number890.3800
Classification Product Code
INI  
Date Received03/19/2009
Decision Date 07/06/2009
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
Recalls CDRH Recalls
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