Device Classification Name |
Prosthesis, Esophageal
|
510(k) Number |
K200860 |
Device Name |
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) |
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 | 878.3610
|
Classification Product Code |
|
Date Received | 04/01/2020 |
Decision Date | 05/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|