510(k) K190182 ยท FRN Pump, Infusion
Unity Subcutaneous Delivery System for Remodulin
| Applicant | DEKA Research & Development, Manchester NH, US |
| Decision | Substantially Equivalent, May 6, 2019 |
| Received | Feb 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190182
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.