The following data is part of a premarket notification filed by Steris Corporations with the FDA for Celerity Hp Chemical Indicator (ci).
| Device ID | K183295 |
| 510k Number | K183295 |
| Device Name: | Celerity HP Chemical Indicator (CI) |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | Steris Corporations 5960 Heisley Road Mentor, OH 44060 |
| Contact | Gregory Land |
| Correspondent | Gregory Land Steris Corporations 5960 Heisley Road Mentor, OH 44060 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-27 |
| Decision Date | 2019-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995164732 | K183295 | 000 |