510(k) K191264 · OQY Intrauterine Tamponade Balloon
Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)
| Applicant | Ujenzi Charitable Trust, Medford MA, US |
| Decision | Substantially Equivalent, Oct 30, 2019 |
| Received | May 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191264
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.