510(k) K830504 ยท BTR Tube, Tracheal (W/Wo Connector)
SURGITEK ULTRA-LO CUFF
| Applicant | Mec/Surgitek Products, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 12, 1983 |
| Received | Feb 16, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830504
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.