Device Classification Name |
Prosthesis, Tracheal, Expandable
|
510(k) Number |
K201342 |
Device Name |
HANAROSTENT Trachea/Bronchium (CCC) |
Applicant |
M.I. Tech Co., Ltd. |
174, Habuk 2-gil, Jinwi-myeon |
Pyeongtaek-si,
KR
17706
|
|
Applicant Contact |
Inae Kim |
Correspondent |
NAMSA |
400 Highway 169 South, Suite 500 |
Minneapolis,
MN
55426
|
|
Correspondent Contact |
Beryl St. Jeanne |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 05/20/2020 |
Decision Date | 12/31/2020 |
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
|
|
|