The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Assert Steam Process Challenge Device.
| Device ID | K162945 |
| 510k Number | K162945 |
| Device Name: | VERIFY ASSERT STEAM Process Challenge Device |
| Classification | Biological Sterilization Process Indicator With Recombinant-dna Plasmid |
| Applicant | STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 |
| Contact | Ganga Kolli |
| Correspondent | Anthony M 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 | 2016-10-21 |
| Decision Date | 2017-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995153035 | K162945 | 000 |
| 10724995153028 | K162945 | 000 |