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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name high intensity ultrasound system for prostate tissue ablation
De Novo Number DEN150011
Device Name Sonablate 450
Requester
sonacare medical, llc
801 e. morehead st.
suite 201
charlotte,  NC  28202
Contact dawn byrd burleson
Regulation Number876.4340
Classification Product Code
PLP  
Date Received03/23/2015
Decision Date 10/09/2015
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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