510(k) K192978 ยท FLF Sterilizer, Ethylene-Oxide Gas
EOGas 4 Ethylene Oxide Gas Sterilizer
| Applicant | Andersen Sterilizers, Inc., Haw River NC, US |
| Decision | Substantially Equivalent, Nov 12, 2020 |
| Received | Oct 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192978
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.