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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K871633
Device Name TRU-SOUND ULTRASOUND THERAPY UNIT
Applicant
Tru-Trac Therapy Products, Inc.
27635 Diaz Rd.
P.O. Box 880
Temecula,  CA  92390
Applicant Contact DONNA L PRILLAMAN
Correspondent
Tru-Trac Therapy Products, Inc.
27635 Diaz Rd.
P.O. Box 880
Temecula,  CA  92390
Correspondent Contact DONNA L PRILLAMAN
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received04/27/1987
Decision Date 05/28/1987
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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