510(k) K110898 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
S.C.O.R.E.S. UNIT
| Applicant | Ammed Surgical Equipment, LLC, Austin TX, US |
| Decision | Substantially Equivalent, Jul 26, 2012 |
| Received | Mar 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2016 | PMBS, LLC The S.C.O.R.E.S. Unit (self contained operating room equipment
sterilization unit) Terminated |
KCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.