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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 ultrasonic urinary stone propulsion device
De Novo Number DEN230082
Device Name Stone Clear (SC-LP9-01)
Requester
sonomotion, inc.
1600 w. hillsdale blvd
suite 105
san mateo,  CA  94402
Contact oren levy
Regulation Number876.4690
Classification Product Code
QNA  
Date Received12/07/2023
Decision Date 10/30/2024
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
Type Direct
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