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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K895690
Device Name ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
Applicant
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Applicant Contact R. J GAGNE
Correspondent
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Correspondent Contact R. J GAGNE
Regulation Number890.5860
Classification Product Code
IMG  
Date Received09/22/1989
Decision Date 02/20/1990
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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