The following data is part of a premarket notification filed by Steris Corporation with the FDA for Ras 12 Rack, Ras 12 Long Rack, Ras Cycle Of The Amsco 7052hp/7053hp Single Chamber Washer/disinfector.
| Device ID | K200577 |
| 510k Number | K200577 |
| Device Name: | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle Of The AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector |
| Classification | Washer, Cleaner, Automated, Endoscope |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Jennifer Nalepka |
| Correspondent | Jennifer Nalepka STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | NVE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-05 |
| Decision Date | 2020-04-03 |