The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Sirius Biological Indicator Challenge Pack.
| Device ID | K073618 |
| 510k Number | K073618 |
| Device Name: | VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2009-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995090036 | K073618 | 000 |