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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K893448
Device Name TRU TRAC TRACTION TABLE
Applicant
Tru-Trac
344-P SW Wilshire
Burleson,  TX  76028
Applicant Contact RICHARD IVY
Correspondent
Tru-Trac
344-P SW Wilshire
Burleson,  TX  76028
Correspondent Contact RICHARD IVY
Regulation Number890.5900
Classification Product Code
ITH  
Date Received05/03/1989
Decision Date 06/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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