510(k) K121678 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
DTAD
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Aug 30, 2012 |
| Received | Jun 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121678
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.