510(k) K991675 ยท FRC Indicator, Biological Sterilization Process
MODIFICATION OF: STERRAD BI TEST PACK
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Jun 15, 1999 |
| Received | May 17, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991675
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.