The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Evolution Medium Steam Sterilizer (models Hc-800 And Hc-1000).
| Device ID | K173490 |
| 510k Number | K173490 |
| Device Name: | Amsco Evolution Medium Steam Sterilizer (Models HC-800 And HC-1000) |
| Classification | Sterilizer, Steam |
| Applicant | STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-02-22 |
| Summary: | summary |