The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Biological Indicator Challenge Pack For Vaporized Vh202 Sterilization.
| Device ID | K092906 |
| 510k Number | K092906 |
| Device Name: | VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert F Sullivan |
| Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2009-12-30 |
| Summary: | summary |