The following data is part of a premarket notification filed by Steris Corporation with the FDA for Vis-u-all Low Temperature Tyvek Sterilization Pouch For V-pro 1 Sterilization System.
| Device ID | K090371 |
| 510k Number | K090371 |
| Device Name: | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | John Robert Scoville, Jr. |
| Correspondent | John Robert Scoville, Jr. STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-13 |
| Decision Date | 2009-05-01 |
| Summary: | summary |