The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Miromatrix Biological Mesh Rs.
| Device ID | K150341 |
| 510k Number | K150341 |
| Device Name: | Miromatrix Biological Mesh RS |
| Classification | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
| Applicant | MIROMATRIX MEDICAL INC. 18683 Bearpath Trail Eden Prairie, MN 55347 |
| Contact | Jeff Ross |
| Correspondent | Miriam C. Provost BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON STREET SUITE 100 Alexandria, VA 22314 |
| Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-05-12 |
| Summary: | summary |