The following data is part of a premarket notification filed by Steris Corporation with the FDA for System 1e Liquid Chemical Sterilant Processing System.
| Device ID | K102462 |
| 510k Number | K102462 |
| Device Name: | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
| Classification | Sterilant, Medical Devices |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert Sullivan |
| Correspondent | Robert Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2010-09-21 |
| Summary: | summary |