The following data is part of a premarket notification filed by Steris Corporation with the FDA for Vis-u-all Low Temperature Sterilization Pouch/tubing.
| Device ID | K183297 |
| 510k Number | K183297 |
| Device Name: | Vis-U-All Low Temperature Sterilization Pouch/Tubing |
| Classification | Wrap, Sterilization |
| Applicant | STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Jennifer Nalepka |
| Correspondent | Jennifer Nalepka STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-27 |
| Decision Date | 2019-01-03 |
| Summary: | summary |