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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 focused ultrasound system for non-thermal, mechanical tissue ablation
De Novo Number DEN220087
Device Name Edison System
Requester
histosonics, inc.
16305 36th ave. n. suite 300
plymouth,  MN  55446
Contact daniel kosednar
Regulation Number878.4405
Classification Product Code
QGM  
Date Received12/02/2022
Decision Date 10/06/2023
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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