510(k) K050664 ยท FRC Indicator, Biological Sterilization Process
SPOR-TEST PA BIOLOGICAL INDICATOR KIT
| Applicant | Getinge USA, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 7, 2005 |
| Received | Mar 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050664
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.