The following data is part of a premarket notification filed by Steris Corporation with the FDA for Pro-lite Sterilization Tray.
| Device ID | K183301 |
| 510k Number | K183301 |
| Device Name: | PRO-LITE Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Jennifer Nalepka |
| Correspondent | Jennifer Nalepka STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-27 |
| Decision Date | 2019-01-03 |
| Summary: | summary |