The following data is part of a premarket notification filed by Aroa Biosurgery Ltd. with the FDA for Endoform Restella.
| Device ID | K183398 |
| 510k Number | K183398 |
| Device Name: | Endoform Restella |
| Classification | Mesh, Surgical |
| 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 | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-07 |
| Decision Date | 2019-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856072005289 | K183398 | 000 |
| 00856072005043 | K183398 | 000 |
| 00856072005074 | K183398 | 000 |
| 00856072005104 | K183398 | 000 |
| 00856072005111 | K183398 | 000 |
| 00856072005135 | K183398 | 000 |
| 00856072005197 | K183398 | 000 |
| 00856072005005 | K183398 | 000 |
| 00856072005012 | K183398 | 000 |
| 00856072005029 | K183398 | 000 |
| 00856072005036 | K183398 | 000 |
| 00856072005142 | K183398 | 000 |