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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 K862579
Device Name TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000
Applicant
Tru-Trac
P.O. Box 880
27635 Diaz Rd.
Temecula,  CA  92390
Applicant Contact JERRY JOHNSON
Correspondent
Tru-Trac
P.O. Box 880
27635 Diaz Rd.
Temecula,  CA  92390
Correspondent Contact JERRY JOHNSON
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/07/1986
Decision Date 08/06/1986
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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