The following data is part of a premarket notification filed by Steris Corporation with the FDA for Resert Xl Hld High Level Disinfectant.
| Device ID | K080420 |
| 510k Number | K080420 |
| Device Name: | RESERT XL HLD HIGH LEVEL DISINFECTANT |
| Classification | Sterilant, Medical Devices |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | John R Scoville Jr. |
| Correspondent | John R Scoville Jr. STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-15 |
| Decision Date | 2008-09-02 |
| Summary: | summary |