Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K120476 |
Device Name |
MACROLYTE DISPERSIVE ELECTRODE |
Applicant |
CONMED CORPORATION |
14603 E. FREMONT AVE. |
CENTENNIAL,
CO
80112
|
|
Applicant Contact |
SHAWN RIEDEL |
Correspondent |
CONMED CORPORATION |
14603 E. FREMONT AVE. |
CENTENNIAL,
CO
80112
|
|
Correspondent Contact |
SHAWN RIEDEL |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/16/2012 |
Decision Date | 06/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|