K020875 is an FDA 510(k) clearance for the TSO3 OZONE STERILIZER, MODEL 125L. This device is classified as a Sterilizer, Ethylene-oxide Gas (Class II - Special Controls, product code FLF).
Submitted by Technologies of Sterilization With Oxone, Tso3, Inc. (Fairport, US). The FDA issued a Cleared decision on August 26, 2003, 526 days after receiving the submission on March 18, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K020875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2002 |
| Decision Date | August 26, 2003 |
| Days to Decision | 526 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLF — Sterilizer, Ethylene-oxide Gas |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |