510(k) K093465 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
FUSION SYSTEM
| Applicant | Eclipsemed Global, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Jan 5, 2010 |
| Received | Nov 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093465
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.