510(k) K894398 ยท FRC Indicator, Biological Sterilization Process
STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE
| Applicant | Pymah Corp., No. Hollywood CA, US |
| Decision | Substantially Equivalent, Sep 11, 1989 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894398
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.