The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Miromatrix Biological Mesh.
| Device ID | K160400 |
| 510k Number | K160400 |
| Device Name: | Miromatrix Biological Mesh |
| Classification | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
| Applicant | MIROMATRIX MEDICAL INC. 10399 WEST 70TH ST Eden Prairie, MN 55344 |
| Contact | Jeff Ross |
| Correspondent | Miriam C. Provost BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON ST SUITE 100 Alexandria, VA 22314 |
| Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-12 |
| Decision Date | 2016-06-08 |
| Summary: | summary |