The following data is part of a premarket notification filed by Steris Corparation with the FDA for Verify Steam Integrating Indicator, Verify Steam Integrating Indicator 5cm.
| Device ID | K213412 |
| 510k Number | K213412 |
| Device Name: | VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corparation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Jennifer Nalepka |
| Correspondent | Jennifer Nalepka STERIS Corparation 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 | 2021-10-19 |
| Decision Date | 2022-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950002718 | K213412 | 000 |