Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K231012 |
Device Name |
CoolSeal Trinity |
Applicant |
Bolder Surgical, LLC |
331 S. 104th Street |
Suite 200 |
Louisville,
CO
80027
|
|
Applicant Contact |
Nicholas Wong |
Correspondent |
Bolder Surgical, LLC |
331 S. 104th Street |
Suite 200 |
Louisville,
CO
80027
|
|
Correspondent Contact |
Nicholas Wong |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/10/2023 |
Decision Date | 11/15/2023 |
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
|
|
|