Device Classification Name |
Elastomer, Silicone Block
|
510(k) Number |
K222748 |
Device Name |
ShiNeo Silicone Implant |
Applicant |
Shineo Technology Co., Ltd |
5F, 207-4, XINSHU ROAD., |
NEW TAIPEI CITY,
TW
24262
|
|
Applicant Contact |
Wan-Chun Lai |
Correspondent |
Shineo Technology Co., Ltd |
5F, 207-4, XINSHU ROAD., |
NEW TAIPEI CITY,
TW
24262
|
|
Correspondent Contact |
Wan-Chun Lai |
Regulation Number | 874.3620
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/12/2022 |
Decision Date | 12/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|