The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Chimeron Medium Steam Sterlilzer.
| Device ID | K112403 |
| 510k Number | K112403 |
| Device Name: | AMSCO CHIMERON MEDIUM STEAM STERLILZER |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151683 | K112403 | 000 |
| 00724995209704 | K112403 | 000 |
| 00724995209698 | K112403 | 000 |
| 00724995209681 | K112403 | 000 |
| 00724995209674 | K112403 | 000 |