510(k) K161101 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
PolypVac Microdebrider (3.3mm and 4.0mm)
| Applicant | Laurimed, LLC, Redwood City CA, US |
| Decision | Substantially Equivalent, Jun 22, 2016 |
| Received | Apr 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161101
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.