Device Classification Name |
prosthesis, tracheal, expandable
|
510(k) Number |
K220424 |
Device Name |
Through the Scope Tracheal Stent System |
Applicant |
Micro-Tech (Nanjing) Co., Ltd. |
No.10 Gaoke Third Road, Nanjing National Hi-Tech |
Industrial Development Zone |
Nanjing,
CN
210032
|
|
Applicant Contact |
Sally He |
Correspondent |
Micro-Tech (Nanjing) Co., Ltd. |
No.10 Gaoke Third Road, Nanjing National Hi-Tech |
Industrial Development Zone |
Nanjing,
CN
210032
|
|
Correspondent Contact |
Sally He |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 02/14/2022 |
Decision Date | 07/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|