Device Classification Name |
Plate, Bone
|
510(k) Number |
K232889 |
Device Name |
METICULY Patient-specific titanium maxillofacial mesh implant |
Applicant |
Meticuly Co., Ltd. |
924 B bldg., Rm. B116-118, B210-212 |
Soi Chula 7, Wang Mai, Pathum Wan |
Bangkok,
TH
10330
|
|
Applicant Contact |
Peeranoot Lohwongwatana |
Correspondent |
MDR Solutions Co., Ltd. |
1435 Kanjanapisek Road |
Bang Khae Nuea, Bang Khae |
Bangkok,
TH
10160
|
|
Correspondent Contact |
Paweena U-Thainual |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 09/18/2023 |
Decision Date | 04/30/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|