K090636 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 Tso3, Inc. (Fairport, US). The FDA issued a Cleared decision on December 2, 2009, 267 days after receiving the submission on March 10, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K090636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2009 |
| Decision Date | December 02, 2009 |
| Days to Decision | 267 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 |