Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K190032 |
Device Name |
Disposable Sclerotherapy Needle |
Applicant |
Hangzhou AGS MedTech CO., Ltd |
Building 5, Building 6, Kangxin Road No.597 |
Yuhang District |
Hangzhou,
CN
310000
|
|
Applicant Contact |
Xiangyong Yu |
Correspondent |
Hangzhou AGS MedTech CO., Ltd |
Building 5, Building 6, Kangxin Road No.597 |
Yuhang District |
Hangzhou,
CN
310000
|
|
Correspondent Contact |
Yangping Fu |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/07/2019 |
Decision Date | 02/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|