510(k) K951295 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
STERRAD STERILIZATION POUCH
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, May 19, 1995 |
| Received | Mar 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2011 | Advanced Sterilization Products Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332.
Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. Terminated |
KCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.