510(k) K093185 ยท GXD Generator, Lesion, Radiofrequency
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
| Applicant | Diros Technology, Inc., Markham, Ontario, CA |
| Decision | Substantially Equivalent, Jan 22, 2010 |
| Received | Oct 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093185
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.