The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Assert Self-contained Biological Indicator.
| Device ID | K162701 |
| 510k Number | K162701 |
| Device Name: | VERIFY Assert Self-Contained Biological Indicator |
| Classification | Biological Sterilization Process Indicator With Recombinant-dna Plasmid |
| Applicant | STERIS CORPORATION 5960 HEISLEY RD Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS CORPORATION 5960 HEISLEY RD Mentor, OH 44060 |
| Product Code | OWP |
| CFR Regulation Number | 880.2805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-28 |
| Decision Date | 2017-03-24 |
| Summary: | summary |