The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco 600 Medium Steam Sterilizer.
| Device ID | K211500 |
| 510k Number | K211500 |
| Device Name: | AMSCO 600 Medium Steam Sterilizer |
| Classification | Sterilizer, Steam |
| Applicant | Steris Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski Steris Corporation 5960 Heisley Rd 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 | 2021-05-14 |
| Decision Date | 2021-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350109400304 | K211500 | 000 |
| 07350109400298 | K211500 | 000 |
| 07350109400281 | K211500 | 000 |