The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Chemical Indicator For S40 Sterilant.
| Device ID | K173428 |
| 510k Number | K173428 |
| Device Name: | VERIFY Chemical Indicator For S40 Sterilant |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Contact | Marcia L. Benedict |
| Correspondent | Marcia L. Benedict STERIS Corporation 5976 Heisley Rd 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 | 2017-11-02 |
| Decision Date | 2018-03-02 |
| Summary: | summary |