510(k) K861463 ยท BTR Tube, Tracheal (W/Wo Connector)
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 6, 1986 |
| Received | Apr 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861463
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.