510(k) K083013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Dec 9, 2008 |
| Received | Oct 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083013
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.