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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 K001166
Device Name ULTRA V THERAPEUTIC ULTRASOUND
Applicant
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Applicant Contact CAMERON MAHON
Correspondent
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Correspondent Contact CAMERON MAHON
Regulation Number890.5860
Classification Product Code
IMG  
Date Received04/10/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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