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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Ultrasound And Accessories
510(k) Number K150019
Device Name TheraVision Ultrasound Ablation System and ACOUSTx Applicators
Applicant
Acoustic Medsystems, Inc.
208 Burwash Ave.
Savoy,  IL  61874
Applicant Contact Yvonne Schleife
Correspondent
Acoustic Medsystems, Inc.
208 Burwash Ave.
Savoy,  IL  61874
Correspondent Contact Yvonne Schleife
Regulation Number878.4400
Classification Product Code
NTB  
Date Received01/05/2015
Decision Date 01/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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