510(k) K181049 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Spectra Optia Apheresis System
| Applicant | Terumobct, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Nov 1, 2018 |
| Received | Apr 20, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181049
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.