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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K073686
Device Name C.T.M. POWER CHAIR, MODEL HS-1500
Applicant
C.T.M. Homecare Product, Inc.
29611 Simmons Rd.
Eugene,  OR  97405
Applicant Contact LINDA J BOVARD
Correspondent
C.T.M. Homecare Product, Inc.
29611 Simmons Rd.
Eugene,  OR  97405
Correspondent Contact LINDA J BOVARD
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/28/2007
Decision Date 02/27/2008
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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