The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Self-contained Biological Indicator For Vaporized (vh2o2) Sterilization Processes.
| Device ID | K090514 |
| 510k Number | K090514 |
| Device Name: | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | John R Scoville |
| Correspondent | John R Scoville STERIS Corporation 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 | 2009-02-26 |
| Decision Date | 2009-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995180300 | K090514 | 000 |