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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 K791976
Device Name DYNASOUND 601
Applicant
Dynawave, Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dynawave, Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5300
Classification Product Code
IMI  
Date Received10/02/1979
Decision Date 01/09/1980
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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