The following data is part of a premarket notification filed by Steris Corporation with the FDA for Celerity 20 Steam Biological Indicator.
| Device ID | K181686 |
| 510k Number | K181686 |
| Device Name: | CELERITY 20 Steam Biological Indicator |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Tony Piotrkowski |
| Correspondent | Tony Piotrkowski STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-26 |
| Decision Date | 2018-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950139889 | K181686 | 000 |