Device Classification Name |
system, ablation, microwave and accessories
|
510(k) Number |
K173756 |
Device Name |
Certus 140 2.45GHz Ablation System |
Applicant |
NeuWave Medical, Inc. |
3529 Anderson Street |
Madison,
WI
53704
|
|
Applicant Contact |
Dan Kosednar |
Correspondent |
NeuWave Medical, Inc. |
3529 Anderson Street |
Madison,
WI
53704
|
|
Correspondent Contact |
Dan Kosednar |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/11/2017 |
Decision Date | 10/24/2018 |
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
|