The following data is part of a premarket notification filed by Steris Corporation with the FDA for Celeritytm 10 Steam Chemical Indicator.
| Device ID | K182724 |
| 510k Number | K182724 |
| Device Name: | CelerityTM 10 STEAM Chemical Indicator |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Rd. Mentor, OH 44060 |
| Contact | Eileen Mccafferty |
| Correspondent | Eileen Mccafferty 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 | 2018-09-28 |
| Decision Date | 2018-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995172188 | K182724 | 000 |