Device Classification Name |
syringe, piston
|
510(k) Number |
K234024 |
Device Name |
HWJECT Auto-disable syringe |
Applicant |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd |
No. 2 Guanyin Road, Taihu Economic Development Zone |
Anqing,
CN
246400
|
|
Applicant Contact |
Bingyi Xiang |
Correspondent |
Shanghai Mind-Link Consulting Co., Ltd. |
1399 Jiangyue Road, Minhang District |
Shanghai,
CN
201114
|
|
Correspondent Contact |
Tanya Wang |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2023 |
Decision Date | 03/19/2024 |
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
|
|
|