510(k) K133133 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
LAURIMED POLYPVAC MICRODEBRIDER
| Applicant | Laurimed, LLC, San Ramon CA, US |
| Decision | Substantially Equivalent, Dec 23, 2013 |
| Received | Sep 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2014 | Laurimed LLC PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which acces Terminated |
ERL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.