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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 K920983
Device Name SONOPULS 590
Applicant
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Applicant Contact ERNEST J HENLEY
Correspondent
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Correspondent Contact ERNEST J HENLEY
Regulation Number890.5300
Classification Product Code
IMI  
Date Received03/02/1992
Decision Date 03/09/1993
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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