Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K130689 |
Device Name |
SYMPHONY RF GENERATOR |
Applicant |
THERMIGEN, INC. |
401 N. CARROLL AVE |
SOUTHLAKE,
TX
76092
|
|
Applicant Contact |
KEVIN O'BRIEN |
Correspondent |
THERMIGEN, INC. |
401 N. CARROLL AVE |
SOUTHLAKE,
TX
76092
|
|
Correspondent Contact |
KEVIN O'BRIEN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/13/2013 |
Decision Date | 11/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|