The following data is part of a premarket notification filed by Polynovo Biomaterials Pty Ltd with the FDA for Novosorb Btm Wound Dressing (2cm X 2cm), Novosorb Btm Wound Dressing (10cm X 10cm), Novosorb Btm Wound Dressing (10cm X 20cm), Novosorb Btm Wound Dressing (20cm X 40cm).
| Device ID | K172140 |
| 510k Number | K172140 |
| Device Name: | NovoSorb BTM Wound Dressing (2cm X 2cm), NovoSorb BTM Wound Dressing (10cm X 10cm), NovoSorb BTM Wound Dressing (10cm X 20cm), NovoSorb BTM Wound Dressing (20cm X 40cm) |
| Classification | Dressing, Wound, Drug |
| Applicant | PolyNovo Biomaterials Pty Ltd Unit 2, 320 Lorimer Street Port Melbourne, AU 3207 |
| Contact | Sue Cho |
| Correspondent | Sue Cho PolyNovo Biomaterials Pty Ltd Unit 2, 320 Lorimer Street 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 | 2017-07-17 |
| Decision Date | 2017-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09349155001229 | K172140 | 000 |
| 09349155001199 | K172140 | 000 |
| 09349155001168 | K172140 | 000 |
| 09349155001137 | K172140 | 000 |
| 09349155000239 | K172140 | 000 |
| 09349155000161 | K172140 | 000 |
| 09349155000130 | K172140 | 000 |
| 09349155000109 | K172140 | 000 |
| 09349155002219 | K172140 | 000 |