The following data is part of a premarket notification filed by Steris Corporation with the FDA for V-pro S2 Low Temperature Sterilization System, V-pro 60 Low Temperature Sterilization System.
| Device ID | K182568 |
| 510k Number | K182568 |
| Device Name: | V-PRO S2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
| Classification | Sterilizer, Chemical |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Bill Brodbeck |
| Correspondent | Bill Brodbeck STERIS Corporation 5960 Heisley Road 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 | 2018-09-18 |
| Decision Date | 2019-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995164096 | K182568 | 000 |