The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco V-pro 1 Low Temperature Sterilization System, Amsco V-pro 1 Plus Low Temperature Sterilization System, V-pro Max Low Temperature Sterilization System, V-pro 60 Low Temperature Sterilization System.
| Device ID | K162413 |
| 510k Number | K162413 |
| Device Name: | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO MaX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
| Classification | Sterilizer, Chemical |
| Applicant | STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Bill Brodbeck |
| Correspondent | Bill Brodbeck STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-29 |
| Decision Date | 2017-03-31 |
| Summary: | summary |