510(k) K080420 ยท MED Sterilant, Medical Devices
RESERT XL HLD HIGH LEVEL DISINFECTANT
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Sep 2, 2008 |
| Received | Feb 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse
Model Number: 4455AW Open, Classified |
MED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.