K080420 is an FDA 510(k) clearance for the RESERT XL HLD HIGH LEVEL DISINFECTANT. This device is classified as a Sterilant, Medical Devices (Class II - Special Controls, product code MED).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 2, 2008, 200 days after receiving the submission on February 15, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K080420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2008 |
| Decision Date | September 02, 2008 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6885 |