510(k) K972747 ยท FRC Indicator, Biological Sterilization Process
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
| Applicant | Propper Mfg. Co., Inc., Long Island NY, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Jul 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972747
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.