510(k) K981497 ยท FRC Indicator, Biological Sterilization Process
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
| Applicant | Steritec Products Mfg Co, Inc., Castle Rock CO, US |
| Decision | Substantially Equivalent, Oct 29, 1998 |
| Received | Apr 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981497
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.