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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 K000084
Device Name ENRAF-NONIUS SONOPULS 190 SYSTEM
Applicant
Henley Healthcare, Inc.
120 Industrial Blvd.
Sugar Land,  TX  77478
Applicant Contact REBECCA STOUT
Correspondent
Henley Healthcare, Inc.
120 Industrial Blvd.
Sugar Land,  TX  77478
Correspondent Contact REBECCA STOUT
Regulation Number890.5300
Classification Product Code
IMI  
Date Received01/12/2000
Decision Date 08/04/2000
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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