The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Miromatrix Wound Matrix.
| Device ID | K140510 |
| 510k Number | K140510 |
| Device Name: | MIROMATRIX WOUND MATRIX |
| Classification | Dressing, Wound, Collagen |
| Applicant | MIROMATRIX MEDICAL INC. 400 N. WASHINGTON ST., STE 100 Alexandria, VA 22314 |
| Contact | Stephen Rhodes |
| Correspondent | Stephen Rhodes MIROMATRIX MEDICAL INC. 400 N. WASHINGTON ST., STE 100 Alexandria, VA 22314 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-28 |
| Decision Date | 2014-06-19 |
| Summary: | summary |