510(k) K230849 ยท OQY Intrauterine Tamponade Balloon
ELLAVI UBT
| Applicant | Sinapi Biomedical (Pty) , Ltd., Stellenbosch, ZA |
| Decision | Substantially Equivalent, Nov 13, 2023 |
| Received | Mar 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230849
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.