K190742 is an FDA 510(k) clearance for the EPIFLO-28, a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Neogenix, LLC Dba Ogenix (Beachwood, US). The FDA issued a Cleared decision on December 13, 2019, 266 days after receiving the submission on March 22, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K190742 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2019 |
| Decision Date | December 13, 2019 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KPJ — Chamber, Oxygen, Topical, Extremity |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5650 |