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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 K934287
Device Name DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR
Applicant
Dynawave, Corp.
2520 Kaneville Ct.
Geneva,  IL  60134
Applicant Contact C.R. KESNER
Correspondent
Dynawave, Corp.
2520 Kaneville Ct.
Geneva,  IL  60134
Correspondent Contact C.R. KESNER
Regulation Number890.5860
Classification Product Code
IMG  
Date Received09/02/1993
Decision Date 04/04/1994
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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