The following data is part of a premarket notification filed by Aroa Biosurgery (formerly Mesynthes Limited) with the FDA for Endoform Plastics And Reconstructive Matrix.
| Device ID | K162461 |
| 510k Number | K162461 |
| Device Name: | Endoform Plastics And Reconstructive Matrix |
| Classification | Mesh, Surgical |
| Applicant | AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) 2 KINGSFORD SMITH PLACE, AIRPORT OAKS Auckland, NZ 2022 |
| Contact | Yasmin Rai |
| Correspondent | Gordon Macfarlane ICON PLC 62 FOREST STREET, SUITE 300 Marlborough, MA 01752 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2016-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421905067423 | K162461 | 000 |
| 09421906017618 | K162461 | 000 |
| 09421906017601 | K162461 | 000 |
| 09421906017748 | K162461 | 000 |
| 09421906017731 | K162461 | 000 |
| 09421906017724 | K162461 | 000 |
| 09421906017717 | K162461 | 000 |
| 09421906017694 | K162461 | 000 |
| 09421906017687 | K162461 | 000 |
| 09421906017663 | K162461 | 000 |
| 09421906017625 | K162461 | 000 |
| 09421906017632 | K162461 | 000 |
| 09421905067416 | K162461 | 000 |
| 09421904065680 | K162461 | 000 |
| 09421904065697 | K162461 | 000 |
| 09421905067317 | K162461 | 000 |
| 09421905067300 | K162461 | 000 |
| 09421904065673 | K162461 | 000 |
| 09421904065666 | K162461 | 000 |
| 09421906017656 | K162461 | 000 |
| 09421906017649 | K162461 | 000 |
| 09421906017670 | K162461 | 000 |