The following data is part of a premarket notification filed by Steris Corporation with the FDA for System 1 Endo Liquid Chemical Sterilant Processing System.
| Device ID | K173256 |
| 510k Number | K173256 |
| Device Name: | System 1 Endo Liquid Chemical Sterilant Processing System |
| Classification | Sterilant, Medical Devices |
| Applicant | Steris Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Contact | Marcia L Benedict |
| Correspondent | Marcia L Benedict Steris Corporation 5976 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 | 2017-10-10 |
| Decision Date | 2018-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995155728 | K173256 | 000 |
| 00724995162801 | K173256 | 000 |
| 00724995162818 | K173256 | 000 |
| 10724995003439 | K173256 | 000 |
| 10724995003422 | K173256 | 000 |
| 10724995003415 | K173256 | 000 |