510(k) K170622 ยท OQY Intrauterine Tamponade Balloon
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 31, 2017 |
| Received | Mar 1, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170622
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.