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, Model 6900.
| Device ID | K182827 |
| 510k Number | K182827 |
| Device Name: | SYSTEM 1 Endo Liquid Chemical Sterilant Processing System, Model 6900 |
| 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 | 2018-10-05 |
| Decision Date | 2019-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995170554 | K182827 | 000 |