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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 K872909
Device Name SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION
Applicant
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Applicant Contact KARL HAUSNER
Correspondent
Elmed, Inc.
60 W. Fay Ave.
Addison,  IL  60101
Correspondent Contact KARL HAUSNER
Regulation Number890.5860
Classification Product Code
IMG  
Date Received07/24/1987
Decision Date 01/13/1988
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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