The following data is part of a premarket notification filed by Exogenesis Corporation with the FDA for Exogenesis Hernia Mesh.
| Device ID | K191545 |
| 510k Number | K191545 |
| Device Name: | Exogenesis Hernia Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Exogenesis Corporation 20 Fortune Drive Billerica, MA 01821 |
| Contact | Joseph Khoury |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-11 |
| Decision Date | 2019-09-26 |
| Summary: | summary |