Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K203150 |
Device Name |
Cool-tip RF Ablation System E Series |
Applicant |
Covidien LLC |
5920 Longbow Drive |
Boulder,
CO
80301
|
|
Applicant Contact |
Liron Bar Yaakov |
Correspondent |
Covidien LLC |
5920 Longbow Drive |
Boulder,
CO
80301
|
|
Correspondent Contact |
Liron Bar Yaakov |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/22/2020 |
Decision Date | 02/25/2022 |
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
|