The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Steam Integrating Indicator.
| Device ID | K152630 |
| 510k Number | K152630 |
| Device Name: | VERIFY STEAM Integrating Indicator |
| Classification | Indicator, Physical/chemical Sterilization Process |
| 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 | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2016-05-12 |
| Summary: | summary |