510(k) K131744 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
| Applicant | Terumobct, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Aug 8, 2013 |
| Received | Jun 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131744
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.