The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Wound Matrix Tf.
| Device ID | K143426 |
| 510k Number | K143426 |
| Device Name: | Wound Matrix TF |
| Classification | Dressing, Wound, Collagen |
| Applicant | MIROMATRIX MEDICAL INC. 18683 Bearpath Trail Eden Prairie, MN 55347 |
| Contact | Jeff Ross |
| Correspondent | Stephen Rhodes BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON ST. SUITE 100 Alexandira, VA 22314 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-01 |
| Decision Date | 2015-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857072005309 | K143426 | 000 |
| 00857072005125 | K143426 | 000 |
| 00857072005132 | K143426 | 000 |
| 00857072005149 | K143426 | 000 |
| 00857072005156 | K143426 | 000 |
| 00857072005163 | K143426 | 000 |
| 00857072005170 | K143426 | 000 |
| 00857072005200 | K143426 | 000 |
| 00857072005217 | K143426 | 000 |
| 00857072005224 | K143426 | 000 |
| 00857072005231 | K143426 | 000 |
| 00857072005248 | K143426 | 000 |
| 00857072005255 | K143426 | 000 |
| 00857072005262 | K143426 | 000 |
| 00857072005293 | K143426 | 000 |
| 00857072005118 | K143426 | 000 |