510(k) K170427 ยท FRC Indicator, Biological Sterilization Process
Anprolene SteriTest
| Applicant | Andersen Sterilizers, Inc., Haw River NC, US |
| Decision | Substantially Equivalent, Oct 31, 2017 |
| Received | Feb 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170427
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.