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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 fluid jet removal system
De Novo Number DEN170024
Device Name AQUABEAM System
Requester
procept biorobotics, corporation
900 island dr., suite 101
redwood city,  CA  94568
Contact michael nketiah
Regulation Number876.4350
Classification Product Code
PZP  
Date Received04/17/2017
Decision Date 12/21/2017
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
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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