Device Classification Name |
Syringe, Antistick
|
510(k) Number |
K222452 |
Device Name |
Disposable Automatically Retractable Safety Syringes (with detachable needle) |
Applicant |
Shantou Wealy Medical Instrument CO.,Ltd. |
North Jinhuan Road (near of Qishan mid-school) |
Shantou,
CN
515064
|
|
Applicant Contact |
Yanjun Zhu |
Correspondent |
Shanghai SUNGO Management Consulting Co. Ltd. |
Room 1401, Dongfang Building, 1500# Century Ave., |
Shanghai,
CN
200122
|
|
Correspondent Contact |
Eva Li |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/15/2022 |
Decision Date | 11/23/2022 |
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
|
|
|