510(k) K092326 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
SMOOTHCOOL
| Applicant | Jeisys Medical, Inc., Greenwood Village CO, US |
| Decision | Substantially Equivalent, Mar 5, 2010 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092326
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.