The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Chimeron Medium Steam Sterilizer.
| Device ID | K112055 | 
| 510k Number | K112055 | 
| Device Name: | AMSCO CHIMERON MEDIUM STEAM STERILIZER | 
| Classification | Sterilizer, Steam | 
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 | 
| Contact | Robert F Sullivan | 
| Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road 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 | 2011-07-19 | 
| Decision Date | 2011-12-16 | 
| Summary: | summary |