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 Number | 876.4340
|
Classification Product Code |
|
Date Received | 03/23/2015 |
Decision Date | 10/09/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|