The following data is part of a premarket notification filed by Nextgen Biologics, Inc. with the FDA for Neomatrix Wound Matrix.
| Device ID | K181330 |
| 510k Number | K181330 |
| Device Name: | NeoMatriX Wound Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | NeXtGen Biologics, Inc. 747 SW 2nd Ave - IMB 5 Gainesville, FL 32601 |
| Contact | Jonelle L. Toothman |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-18 |
| Decision Date | 2018-10-11 |
| Summary: | summary |