The following data is part of a premarket notification filed by Reprise Biomedical, Inc. with the FDA for Miro3d Wound Matrix.
| Device ID | K221520 |
| 510k Number | K221520 |
| Device Name: | Miro3D Wound Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | Reprise Biomedical, Inc. 17400 Medina Road Suite 100 Plymouth, MN 55447 |
| Contact | Herzog Kathy |
| Correspondent | Herzog Kathy Reprise Biomedical, Inc. 17400 Medina Road Suite 100 Plymouth, MN 55447 |
| 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 | 2022-05-25 |
| Decision Date | 2022-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857072005347 | K221520 | 000 |
| 00857072005330 | K221520 | 000 |
| 00857072005323 | K221520 | 000 |
| 00857072005316 | K221520 | 000 |
| 00857072005446 | K221520 | 000 |
| 00857072005439 | K221520 | 000 |
| 00857072005422 | K221520 | 000 |
| 00857072005415 | K221520 | 000 |