Device Classification Name |
Syringe, Antistick
|
510(k) Number |
K211753 |
Device Name |
Sterile Syringe With Safety Needle |
Applicant |
Jiangxi Hongda Medical Equipment Group Ltd. |
No. 39 South Shengli Road |
Nanchang,
CN
331700
|
|
Applicant Contact |
Xiaohua Yang |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O.BOX 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5860 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/07/2021 |
Decision Date | 10/14/2021 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|