510(k) K034004 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Mar 3, 2004 |
| Received | Dec 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034004
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.