510(k) K113520 ยท MED Sterilant, Medical Devices
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Feb 21, 2012 |
| Received | Nov 29, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2013 | Steris Corporation SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical ster Terminated |
MLR | None listed |
| Jun 26, 2013 | Steris Corporation Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060
QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart a Terminated |
MED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.