510(k) K042216 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
COOL-TIP RF ABLATION SYSTEM
| Applicant | Valleylab, Boulder CO, US |
| Decision | Substantially Equivalent, Nov 12, 2004 |
| Received | Aug 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042216
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.