The following data is part of a premarket notification filed by Neogenix, Llc Dba Ogenix with the FDA for Epiflo-28.
| Device ID | K190742 |
| 510k Number | K190742 |
| Device Name: | EPIFLO-28 |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | Neogenix, LLC Dba Ogenix 3401 Enterprise Pkwy, Suite 340 Beachwood, OH 44122 |
| Contact | Srinivasan Sarangapani |
| Correspondent | Srinivasan Sarangapani Neogenix, LLC Dba Ogenix 3401 Enterprise Pkwy, Suite 340 Beachwood, OH 44122 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-22 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855526003086 | K190742 | 000 |