The following data is part of a premarket notification filed by Aroa Biosurgery Limited (formerly Mesynthes Limited) with the FDA for Endoform Reconstructive Template.
| Device ID | K153633 |
| 510k Number | K153633 |
| Device Name: | Endoform Reconstructive Template |
| Classification | Mesh, Surgical |
| Applicant | Aroa Biosurgery Limited (Formerly Mesynthes Limited) 2 Kingsford Smith Place, Airport Oaks Auckland, NZ 2022 |
| Contact | Yasmin Rai |
| Correspondent | Gordon Macfarlane ICON Plc 62 Forest Street Marlborough, MA 01752 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421904065413 | K153633 | 000 |
| 09421904065291 | K153633 | 000 |
| 09421904065284 | K153633 | 000 |
| 09421904065277 | K153633 | 000 |
| 09421904065260 | K153633 | 000 |
| 09421904065253 | K153633 | 000 |
| 09421904065246 | K153633 | 000 |
| 09421904065239 | K153633 | 000 |
| 09421904065222 | K153633 | 000 |
| 09421904065307 | K153633 | 000 |
| 09421904065314 | K153633 | 000 |
| 09421904065321 | K153633 | 000 |
| 09421904065406 | K153633 | 000 |
| 09421904065390 | K153633 | 000 |
| 09421904065383 | K153633 | 000 |
| 09421904065376 | K153633 | 000 |
| 09421904065369 | K153633 | 000 |
| 09421904065352 | K153633 | 000 |
| 09421904065345 | K153633 | 000 |
| 09421904065338 | K153633 | 000 |
| 09421904065215 | K153633 | 000 |