Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K220060 |
Device Name |
Pre-filled Syringe with Saline |
Applicant |
Jiangsu Caina Medical Co., Ltd. |
No.23, Huanxi Rd, Zhutang Town |
Jiangyin,
CN
214415
|
|
Applicant Contact |
Jianwei Pan |
Correspondent |
Mid-Link Consulting Co.,Ltd |
P.O Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/10/2022 |
Decision Date | 06/10/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|