The following data is part of a premarket notification filed by Polynovo Biomaterials Pty Ltd with the FDA for Novosorb Matrix.
| Device ID | K221686 |
| 510k Number | K221686 |
| Device Name: | NovoSorb Matrix |
| Classification | Dressing, Wound, Drug |
| Applicant | PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne, AU 3207 |
| Contact | Tarun Nekkenti |
| Correspondent | Tarun Nekkenti PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne, AU 3207 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-10 |
| Decision Date | 2022-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09349155001328 | K221686 | 000 |
| 09349155001298 | K221686 | 000 |
| 09349155001359 | K221686 | 000 |