The following data is part of a premarket notification filed by Tso3 Inc. with the FDA for Tso3 Ozone Sterilization Wrap.
| Device ID | K080198 |
| 510k Number | K080198 |
| Device Name: | TSO3 OZONE STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-05-30 |
| Summary: | summary |