K190005 is an FDA 510(k) clearance for the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Sterilucent, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 13, 2019, 254 days after receiving the submission on January 2, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K190005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2019 |
| Decision Date | September 13, 2019 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR - Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |