The following data is part of a premarket notification filed by Aroa Biosurgery Ltd. with the FDA for Endoform Reconstructive Template - Non Absorbable.
| Device ID | K181935 |
| 510k Number | K181935 |
| Device Name: | Endoform Reconstructive Template - Non Absorbable |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| Contact | Tina O'brien |
| Correspondent | Tina O'brien Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks, NZ 2022 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-19 |
| Decision Date | 2018-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421904065758 | K181935 | 000 |
| 09421904065741 | K181935 | 000 |
| 09421904065734 | K181935 | 000 |
| 09421904065727 | K181935 | 000 |
| 09421904065710 | K181935 | 000 |
| 09421904065703 | K181935 | 000 |