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 | K170956 |
| 510k Number | K170956 |
| Device Name: | SYSTEM 1E Liquid Chemical Sterilant Processing System |
| Classification | Sterilant, Medical Devices |
| Applicant | STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Tricia Cregger |
| Correspondent | Tricia Cregger STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995171827 | K170956 | 000 |
| 00724995157449 | K170956 | 000 |