Device Classification Name |
high intensity ultrasound system for prostate tissue ablation
|
510(k) Number |
K153023 |
Device Name |
Ablatherm Integrated Imaging |
Applicant |
EDAP TECHNOMED, INC. |
2201 DENTON DR., SUITE 110 |
AUSTIN,
TX
78758
|
|
Applicant Contact |
MARC OCZACHOWSKI |
Correspondent |
EDAP TECHNOMED, INC. |
2201 DENTON DR., SUITE 110 |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
JOHN C REWCASTLE |
Regulation Number | 876.4340
|
Classification Product Code |
|
Date Received | 10/15/2015 |
Decision Date | 11/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00295802
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|