The following data is part of a premarket notification filed by Steris Corporation with the FDA for System 1e Liquid Chemical Sterilant Processing System, System 1 Endo Liquid Chemical Sterilant Processing System, Model P6800, System 1 Endo Liquid Chemical Sterilant Processing System, Model P6900.
| Device ID | K192929 |
| 510k Number | K192929 |
| Device Name: | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Model P6900 |
| Classification | Sterilant, Medical Devices |
| 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 | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-17 |
| Decision Date | 2019-12-10 |