The following data is part of a premarket notification filed by Bolder Surgical, Llc with the FDA for Coolseal Trinity (30 Cm Shaft, 37 Cm Shaft, And 44 Cm Shaft).
| Device ID | K203183 |
| 510k Number | K203183 |
| Device Name: | CoolSeal Trinity (30 Cm Shaft, 37 Cm Shaft, And 44 Cm Shaft) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Bolder Surgical, LLC 331 S. 104th Street, Suite 200 Louisville, CO 80027 |
| Contact | Nicholas Wong |
| Correspondent | Nicholas Wong Bolder Surgical, LLC 331 S. 104th Street, Suite 200 Louisville, CO 80027 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-27 |
| Decision Date | 2021-05-06 |