The following data is part of a premarket notification filed by Steris Corporation with the FDA for Steris Amsco Millennium Steam Sterilizer.
| Device ID | K000077 |
| 510k Number | K000077 |
| Device Name: | STERIS AMSCO MILLENNIUM STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Raymond Ursick |
| Correspondent | Raymond Ursick STERIS Corporation 5960 Heisley Road 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 | 2000-01-11 |
| Decision Date | 2000-03-17 |