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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 K883893
Device Name OMNISOUND(TM) 3000
Applicant
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Applicant Contact MICHAEL R RONAYNE
Correspondent
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Correspondent Contact MICHAEL R RONAYNE
Regulation Number890.5860
Classification Product Code
IMG  
Date Received09/14/1988
Decision Date 11/01/1988
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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