The following data is part of a premarket notification filed by Aroa Biosurgery with the FDA for Endoform Topical Matrix.
| Device ID | K171231 |
| 510k Number | K171231 |
| Device Name: | Endoform Topical Matrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | Aroa Biosurgery 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| Contact | Tina O’brien |
| Correspondent | Tina O’brien Aroa Biosurgery 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| 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 | 2017-04-27 |
| Decision Date | 2017-06-14 |
| Summary: | summary |