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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K881211
Device Name TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
Applicant
Tru-Trac Therapy Products, Inc.
27635 Diaz Rd.
P.O. Box 880
Temecula,  CA  92390
Applicant Contact DONNA L HAUSLER
Correspondent
Tru-Trac Therapy Products, Inc.
27635 Diaz Rd.
P.O. Box 880
Temecula,  CA  92390
Correspondent Contact DONNA L HAUSLER
Regulation Number890.5300
Classification Product Code
IMI  
Date Received03/21/1988
Decision Date 05/11/1988
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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