The following data is part of a premarket notification filed by Steris Corporation with the FDA for Modification To Resert Xl Hld High Level Disinfectant.
| Device ID | K091022 |
| 510k Number | K091022 |
| Device Name: | MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT |
| Classification | Sterilant, Medical Devices |
| Applicant | STERIS Corporation REGULATORY AFFAIRS/CORPORATE 5960 HEISLEY RD. Mentor, OH 44060 |
| Contact | John Scoville Jr. |
| Correspondent | John Scoville Jr. STERIS Corporation REGULATORY AFFAIRS/CORPORATE 5960 HEISLEY RD. 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 | 2009-04-09 |
| Decision Date | 2010-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10068460505197 | K091022 | 000 |