510(k) K811033 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SHILEY LOW PRESSURE THIN-CUFFED TRACH
| Applicant | Shiley, Inc., Walker MI, US |
| Decision | Substantially Equivalent, May 13, 1981 |
| Received | Apr 15, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811033
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.