K190742 is an FDA 510(k) clearance for the EPIFLO-28. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K190742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |