510(k) K010465 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
DENSTAT
| Applicant | Elmed, Inc., Addison IL, US |
| Decision | Substantially Equivalent, May 14, 2001 |
| Received | Feb 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010465
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.