510(k) K083295 ยท JOJ Indicator, Physical/Chemical Sterilization Process
SERIM DISINTEK GTA 2.1%, MODEL: 5164
| Applicant | Serim Research Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Mar 16, 2009 |
| Received | Nov 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083295
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.