The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco V-pro 1 Low, V-pro 1 Plus, V-pro Max Low Temperature Sterilization System.
| Device ID | K131120 |
| 510k Number | K131120 |
| Device Name: | AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX 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 | 2013-04-22 |
| Decision Date | 2013-07-16 |
| Summary: | summary |