The following data is part of a premarket notification filed by Tso3 Inc with the FDA for Sterizone(r) Vp4 Sterilizer.
| Device ID | K190260 |
| 510k Number | K190260 |
| Device Name: | STERIZONE(R) VP4 Sterilizer |
| Classification | Two Or More Sterilant Sterilizer |
| Applicant | TSO3 Inc 2505 Avenue Dalton Quebec, CA G1p 3s5 |
| Contact | Sandy Cliche |
| Correspondent | Cynthia G. Pritchard BioTechnology Transfer, LLC 1016 Tobiano Lane Raleigh, NC 27614 |
| Product Code | PJJ |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-07-19 |