The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Evolution Medium Steam Sterilizer.
| Device ID | K082435 |
| 510k Number | K082435 |
| Device Name: | AMSCO EVOLUTION 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-22 |
| Decision Date | 2008-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350109400274 | K082435 | 000 |
| 07350109400267 | K082435 | 000 |
| 07350109400175 | K082435 | 000 |
| 07350109400168 | K082435 | 000 |