The following data is part of a premarket notification filed by Tso3 Inc with the FDA for Sterizone Sterilizer.
| Device ID | K153689 |
| 510k Number | K153689 |
| Device Name: | STERIZONE Sterilizer |
| Classification | Two Or More Sterilant Sterilizer |
| Applicant | TSO3 INC 2505, AVENUE DALTON Quebec, CA G1p 3s5 |
| Contact | Nathalie Racette |
| Correspondent | Thomas Richards IM3, INC 7720 NE HWY 99, SUITE D#110 Vancouver, WA 98665 |
| Product Code | PJJ |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-06-30 |
| Summary: | summary |