510(k) K101535 ยท OQY Intrauterine Tamponade Balloon
BT-CATH
| Applicant | Utah Medical Products, Inc., Midvale UT, US |
| Decision | Substantially Equivalent, Jan 11, 2011 |
| Received | Jun 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101535
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.