Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K202437 |
Device Name |
Infusion Sets for Single Use |
Applicant |
Jiangsu Suyun Medical Materials Co., Ltd. |
No.18 Jinaqiao Road, Dapu Industrial Park, |
Lianyungang Economic Development Zone |
Lianyungang,
CN
222002
|
|
Applicant Contact |
Guangning Xu |
Correspondent |
Mid-Link Consulting Co., Ltd. |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/25/2020 |
Decision Date | 03/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|