Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K172671 |
Device Name |
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal |
Applicant |
Conmed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Applicant Contact |
Lisa Anderson |
Correspondent |
Conmed Corporation |
525 French Road |
Utica,
NY
13502
|
|
Correspondent Contact |
Lisa Anderson |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/05/2017 |
Decision Date | 10/04/2017 |
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
|