The following data is part of a premarket notification filed by Steris with the FDA for Vis-u-all Low Temperature Sterilization Pouches/tubing, Pro-lite Sterilization Trays.
| Device ID | K222440 |
| 510k Number | K222440 |
| Device Name: | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays |
| Classification | Wrap, Sterilization |
| Applicant | Steris 5960 Heisey Road Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski Steris 5960 Heisey Road Mentor, OH 44060 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-12 |
| Decision Date | 2022-09-09 |