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 | K131078 |
| 510k Number | K131078 |
| Device Name: | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
| Classification | Sterilant, Medical Devices |
| Applicant | STERIS Corporation 5960 HEISLEY Mentor, OH 44060 |
| Contact | Marcia L Benedict |
| Correspondent | Marcia L Benedict STERIS Corporation 5960 HEISLEY 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 | 2013-04-17 |
| Decision Date | 2013-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333244287 | K131078 | 000 |
| 04961333244270 | K131078 | 000 |
| 04961333244263 | K131078 | 000 |