The following data is part of a premarket notification filed by Tso3 Inc. with the FDA for Tso3 Ozone Sterilizer, Model 125l.
| Device ID | K090636 |
| 510k Number | K090636 |
| Device Name: | TSO3 OZONE STERILIZER, MODEL 125L |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | TSO3 INC. 33 BLACK WATCH TRAIL Fairport, NY 14450 |
| Contact | Charles O Hancock |
| Correspondent | Charles O Hancock TSO3 INC. 33 BLACK WATCH TRAIL Fairport, NY 14450 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-10 |
| Decision Date | 2009-12-02 |
| Summary: | summary |