The following data is part of a premarket notification filed by Tso3 Inc., Now A Part Of Stryker with the FDA for Sterizone Vp4 Test Pack.
| Device ID | K203560 |
| 510k Number | K203560 |
| Device Name: | STERIZONE VP4 Test Pack |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | TSO3 Inc., Now A Part Of Stryker 2505, Avenue Dalton Québec, CA G1p 3s5 |
| Contact | Karan Modi |
| Correspondent | Karan Modi TSO3 Inc., Now A Part Of Stryker 2505, Avenue Dalton Québec, CA G1p 3s5 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-03-24 |