Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K192715 |
Device Name |
CRF Radiofrequency Ablation System |
Applicant |
Cambridge Interventional LLC |
78 Cambridge Street |
Burlington,
MA
01803
|
|
Applicant Contact |
Michael A. Arnold |
Correspondent |
Cambridge Interventional LLC |
78 Cambridge Street |
Burlington,
MA
01803
|
|
Correspondent Contact |
Michael A. Arnold |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/27/2019 |
Decision Date | 01/07/2020 |
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
|