The following data is part of a premarket notification filed by Neogenix, Llc with the FDA for Epiflo(r).
| Device ID | K120764 |
| 510k Number | K120764 |
| Device Name: | EPIFLO(R) |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | NEOGENIX, LLC 3401 ENTERPRISE PKWY SUITE 340 Beachwood, OH 44122 |
| Contact | Srinivasan Sarangapani |
| Correspondent | Srinivasan Sarangapani NEOGENIX, LLC 3401 ENTERPRISE PKWY SUITE 340 Beachwood, OH 44122 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-03-13 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855526003062 | K120764 | 000 |
| 00855526003024 | K120764 | 000 |