The following data is part of a premarket notification filed by Polynovo Biomaterials Pty Ltd with the FDA for Btm Wound Dressing.
| Device ID | K142879 |
| 510k Number | K142879 |
| Device Name: | BTM Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | POLYNOVO BIOMATERIALS PTY LTD UNIT 2, 320 LORIMER STREET Port Melbourne, AU 3207 |
| Contact | Philip Powell |
| Correspondent | Ivy Cheng 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-02 |
| Decision Date | 2015-12-23 |
| Summary: | summary |