The following data is part of a premarket notification filed by Tso3 Inc. with the FDA for Sterizone Sterilizer.
| Device ID | K141163 |
| 510k Number | K141163 |
| Device Name: | STERIZONE STERILIZER |
| Classification | Two Or More Sterilant Sterilizer |
| Applicant | TSO3 INC. 512F NE 81ST STREET, SUITE 110 Vancouver, WA 98665 |
| Contact | Thomas Richards, Ph.d. |
| Correspondent | Thomas Richards, Ph.d. TSO3 INC. 512F NE 81ST STREET, SUITE 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 | 2014-05-05 |
| Decision Date | 2014-12-17 |
| Summary: | summary |