510(k) K091958 ยท OQY Intrauterine Tamponade Balloon
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
| Applicant | Glenveigh Surgical, LLC, Swanee GA, US |
| Decision | Substantially Equivalent, Apr 30, 2010 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091958
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.