510(k) K091310 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682
| Applicant | Dfine, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Aug 11, 2010 |
| Received | May 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091310
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.