510(k) K190104 ยท MED Sterilant, Medical Devices
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
| Applicant | Steris Corporations, Mentor OH, US |
| Decision | Substantially Equivalent, Mar 22, 2019 |
| Received | Jan 22, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190104
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.