510(k) K203183 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
| Applicant | Bolder Surgical, LLC, Louisville CO, US |
| Decision | Substantially Equivalent, May 6, 2021 |
| Received | Oct 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203183
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.