Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K140658 |
Device Name |
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES |
Applicant |
CONMED CORPORATION |
525 FRENCH RD. |
UTICA,
NY
13502
|
|
Applicant Contact |
SANDY LECLAIR |
Correspondent |
CONMED CORPORATION |
525 FRENCH RD. |
UTICA,
NY
13502
|
|
Correspondent Contact |
SANDY LECLAIR |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/14/2014 |
Decision Date | 07/10/2014 |
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
|
Recalls |
CDRH Recalls
|