Device Classification Name |
prosthesis, tracheal, expandable
|
510(k) Number |
K212403 |
Device Name |
Tracheal Stent System (Y-Shaped) |
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 | 08/02/2021 |
Decision Date | 10/30/2021 |
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
|
|
|