510(k) K111391 ยท FRC Indicator, Biological Sterilization Process
STERRAD (R) 100NX DUO CYCLE TEST PACK
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Sep 26, 2012 |
| Received | May 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111391
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.