The following data is part of a premarket notification filed by Steris Corporations with the FDA for Verify All-in-one Steam Reusable Test Pack, Verify All-in-one Steam Reusable Test Pack With Step Counter, Verify All-in-one Steam Reusable Test Pack With Tracker Tag.
| Device ID | K182931 |
| 510k Number | K182931 |
| Device Name: | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack With Step Counter, VERIFY All-In-One STEAM Reusable Test Pack With Tracker Tag |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Steris Corporations 5960 Heisley Road Mentor, OH 44060 |
| Contact | Jennifer Nalepka |
| Correspondent | Jennifer Nalepka Steris Corporations 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-22 |
| Decision Date | 2018-11-20 |
| Summary: | summary |