The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Evolution Medium Steam Sterilizer (models Hc-900 And Hc-1200),evolution Automated Loading And Unloading System (alus); Amsco Evolutionmedium Steam Sterilizer (models Hc-600 And Hc-1500),evolution Automated Loading And Unloading System (alus); A.
| Device ID | K203061 |
| 510k Number | K203061 |
| Device Name: | Amsco Evolution Medium Steam Sterilizer (Models HC-900 And HC-1200),Evolution Automated Loading And Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 And HC-1500),Evolution Automated Loading And Unloading System (ALUS); A |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-08 |
| Decision Date | 2020-11-06 |