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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 K070602
Device Name C.T.M. MOBILITY SCOOTER# HS-265
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 Received03/05/2007
Decision Date 04/02/2007
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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