510(k) K203640 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CoolSeal Reveal
| Applicant | Bolder Surgical, LLC, Louisville CO, US |
| Decision | Substantially Equivalent, May 6, 2021 |
| Received | Dec 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203640
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.