510(k) K180478 ยท PCT Prostate Immobilizer Rectal Balloon
RectalPro 75 Endorectal Balloon
| Applicant | Qlrad International , Ltd., Almere, NL |
| Decision | Substantially Equivalent, Nov 13, 2018 |
| Received | Feb 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180478
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.