The following data is part of a premarket notification filed by Steris Corporation with the FDA for Celerity Hp Chemical Indicator, Celerity Vaporized Vh2o2 Process Indicator Adhesive Label, Verify V24 Self-contained Biological Indicator Vial Label.
| Device ID | K192020 |
| 510k Number | K192020 |
| Device Name: | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44077 |
| Contact | Gregory Land |
| Correspondent | Gregory Land STERIS Corporation 5960 Heisley Road Mentor, OH 44077 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2019-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995190665 | K192020 | 000 |
| 50724995164749 | K192020 | 000 |