Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K183398 |
Device Name |
Endoform Restella |
Applicant |
Aroa Biosurgery Ltd. |
2 Kingsford Smith Place |
Airport Oaks,
NZ
2022
|
|
Applicant Contact |
Tina O’Brien |
Correspondent |
Aroa Biosurgery Ltd. |
2 Kingsford Smith Place |
Airport Oaks,
NZ
2022
|
|
Correspondent Contact |
Tina O’Brien |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/07/2018 |
Decision Date | 04/11/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|