The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Sixcess Steam Indicators, Verify Sixcess Flash Indicators, Verify Bowie Dick Test Pack, Verify Sixcess Challenge Pack, Verify Sixcess Fp Challenge Pack.
| Device ID | K162758 |
| 510k Number | K162758 |
| Device Name: | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack |
| Classification | Indicator, Physical/chemical Sterilization Process |
| 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 | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-03-21 |
| Summary: | summary |