Device Classification Name |
syringe, antistick
|
510(k) Number |
K193022 |
Device Name |
Retractable Safety Insulin Syringe |
Applicant |
Jiangsu Caina Medical Co.,Ltd. |
No.23, Huanxi Road, Zhutang Town |
Jiangyin,
CN
214425
|
|
Applicant Contact |
Xinyan Ruan |
Correspondent |
Jiangsu Caina Medical Co.,Ltd. |
No.23, Huanxi Road, Zhutang Town |
Jiangyin,
CN
214415
|
|
Correspondent Contact |
Xinyan Ruan |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 10/30/2019 |
Decision Date | 07/20/2020 |
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
|
|
|