The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Miromatrix Biological Mesh Tw.
| Device ID | K162570 |
| 510k Number | K162570 |
| Device Name: | Miromatrix Biological Mesh TW |
| Classification | Mesh, Surgical |
| Applicant | Miromatrix Medical Inc. 18683 Bearpath Trail 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 | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2017-02-16 |
| Summary: | summary |