Device Classification Name |
mesh, surgical
|
510(k) Number |
K153633 |
Device Name |
Endoform Reconstructive Template |
Applicant |
Aroa Biosurgery Limited (Formerly Mesynthes Limited) |
2 Kingsford Smith Place, Airport Oaks |
Auckland,
NZ
2022
|
|
Applicant Contact |
Yasmin Rai |
Correspondent |
ICON plc |
62 Forest Street |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Gordon MacFarlane |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/18/2015 |
Decision Date | 03/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|