The following data is part of a premarket notification filed by Technologies Of Sterilization With Oxone, Tso3 Inc with the FDA for Tso3 Ozone Chemical Indicator.
| Device ID | K021161 |
| 510k Number | K021161 |
| Device Name: | TSO3 OZONE CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC 33 BLACK WATCH TRAIL Fairport, NY 14450 |
| Contact | Charles O Hancock |
| Correspondent | Charles O Hancock TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC 33 BLACK WATCH TRAIL Fairport, NY 14450 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-11 |
| Decision Date | 2003-08-27 |
| Summary: | summary |