510(k) K083031 ยท BTO Tube, Tracheostomy (W/Wo Connector)
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
| Applicant | Smiths Medical Asd, Inc., Hythe, Kent, GB |
| Decision | Substantially Equivalent, Aug 18, 2009 |
| Received | Oct 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083031
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.