Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K223584 |
Device Name |
Pre-Filled Normal Saline Flush Syringe |
Applicant |
Anhui Tianyang Pharmaceutical Co., Ltd. |
46 Tiantong Road, Tianchang City, Anhui Province |
Tianchang,
CN
|
|
Applicant Contact |
Zhang Shunlin |
Correspondent |
Anhui Tianyang Pharmaceutical Co., Ltd. |
46 Tiantong Road, Tianchang City, Anhui Province |
Tianchang,
CN
|
|
Correspondent Contact |
Zhang Shunlin |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/01/2022 |
Decision Date | 08/12/2023 |
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
|
|
|