510(k) K761190 ยท BTO Tube, Tracheostomy (W/Wo Connector)
TRACHEOSTOMY CARE KIT
| Applicant | Superior Plastic Products Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 16, 1976 |
| Received | Dec 6, 1976 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K761190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | Cardinal Health 200, LLC TRACH KIT W/HYDROGEN & SALI Open, Classified |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.