510(k) K071537 ยท FRC Indicator, Biological Sterilization Process
STERRAD 100NX TEST PACK
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Dec 18, 2007 |
| Received | Jun 5, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071537
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.