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510(k) DEN150011

Sonablate 450 by Sonacare Medical, LLC — Product Code PLP

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 9, 2015
Date Received
March 23, 2015
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class
Class II
Regulation Number
876.4340
Review Panel
GU
Submission Type

Prostate tissue ablation

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