510(k) K031647 ยท JOJ Indicator, Physical/Chemical Sterilization Process
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
| Applicant | Getinge USA, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jul 29, 2003 |
| Received | May 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031647
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.