Device Classification Name |
High Intensity Ultrasound System For Prostate Tissue Ablation
|
510(k) Number |
K160942 |
Device Name |
Sonablate |
Applicant |
SonaCare Medical, LLC |
10130 PERIMETER PARKWAY, SUITE 250 |
CHARLOTTE,
NC
28216
|
|
Applicant Contact |
DAVID M. HERNON |
Correspondent |
SONACARE MEDICAL, LLC |
10130 PERIMETER PARKWAY, SUITE 250 |
CHARLOTTE,
NC
28216
|
|
Correspondent Contact |
DAVID M. HERNON |
Regulation Number | 876.4340
|
Classification Product Code |
|
Date Received | 04/05/2016 |
Decision Date | 12/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|