The following data is part of a premarket notification filed by Steris with the FDA for Celerity 20 Hp Challenge Pack.
| Device ID | K220473 |
| 510k Number | K220473 |
| Device Name: | CELERITY 20 HP Challenge Pack |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERIS 5960 Heisley Rd. Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS 5960 Heisley Rd. Mentor, OH 44060 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-18 |
| Decision Date | 2022-03-18 |