The following data is part of a premarket notification filed by Proxy Biomedical Ltd. with the FDA for Vitamesh Macroporous Pp Surgical Mesh.
| Device ID | K172636 |
| 510k Number | K172636 |
| Device Name: | VitaMESH Macroporous PP Surgical Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Proxy Biomedical Ltd. Coilleach, Spiddal Galway, IE |
| Contact | Adrienne Tierney |
| Correspondent | Elaine Duncan Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2018-04-30 |
| Summary: | summary |