The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Evolution Series Steam Sterilizer, Model: Hc-2000 And Hc-3000.
| Device ID | K092490 |
| 510k Number | K092490 |
| Device Name: | AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 |
| 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 | 2009-08-13 |
| Decision Date | 2009-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151577 | K092490 | 000 |
| 00724995151560 | K092490 | 000 |
| 00724995151553 | K092490 | 000 |
| 00724995151546 | K092490 | 000 |