K080198 is an FDA 510(k) clearance for the TSO3 OZONE STERILIZATION WRAP. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Tso3, Inc. (Fairport, US). The FDA issued a Cleared decision on May 30, 2008, 126 days after receiving the submission on January 25, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K080198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2008 |
| Decision Date | May 30, 2008 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |