K140464 is an FDA 510(k) clearance for the STERILUCENT PSD-85 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 October 31, 2014, 249 days after receiving the submission on February 24, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K140464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2014 |
| Decision Date | October 31, 2014 |
| Days to Decision | 249 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 |