Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K151229 |
Device Name |
ABC D-FLEX PROBE |
Applicant |
CONMED CORPORATION |
525 FRENCH ROAD |
UTICA,
NY
11502
|
|
Applicant Contact |
SANDY LECLAIR |
Correspondent |
CONMED CORPORATION |
525 FRENCH ROAD |
UTICA,
NY
11502
|
|
Correspondent Contact |
Lisa B Anderson |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/07/2015 |
Decision Date | 06/02/2016 |
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
|