The following data is part of a premarket notification filed by Steris Corporation with the FDA for V-pro 60 A Low Tempurature Strilization Systems, V-pro S2 Low Temperature Sterilization Systems.
| Device ID | K190917 |
| 510k Number | K190917 |
| Device Name: | V-PRO 60 A Low Tempurature Strilization Systems, V-PRO S2 Low Temperature Sterilization Systems |
| Classification | Sterilizer, Chemical |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-09 |
| Decision Date | 2019-05-09 |