510(k) K223015 · MLR Sterilizer, Chemical
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
| Applicant | Plasmapp Co,., Ltd., Daejeon, KR |
| Decision | Substantially Equivalent, May 9, 2023 |
| Received | Sep 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223015
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.