The following data is part of a premarket notification filed by Shantou Wealy Medical Instrument Co.,ltd. with the FDA for Disposable Automatically Retractable Safety Syringes (with Detachable Needle).
| Device ID | K222452 |
| 510k Number | K222452 |
| Device Name: | Disposable Automatically Retractable Safety Syringes (with Detachable Needle) |
| Classification | Syringe, Antistick |
| Applicant | Shantou Wealy Medical Instrument CO.,Ltd. North Jinhuan Road (near Of Qishan Mid-school) Shantou, CN 515064 |
| Contact | Yanjun Zhu |
| Correspondent | Eva Li Shanghai SUNGO Management Consulting Co. Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai, CN 200122 |
| Product Code | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-15 |
| Decision Date | 2022-11-23 |