510(k) K923878 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Dec 29, 1992 |
| Received | Aug 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2006 | Smiths Medical ASD, Inc. Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care;
REF HU05JS55NNA112S. Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.