The following data is part of a premarket notification filed by Zhejiang Lingyang Medical Apparatus Co., Ltd. with the FDA for Automatically Retractable Safety Syringe.
| Device ID | K213077 |
| 510k Number | K213077 |
| Device Name: | Automatically Retractable Safety Syringe |
| Classification | Syringe, Antistick |
| Applicant | Zhejiang Lingyang Medical Apparatus Co., Ltd. Baishuiyang Town Linhai, CN 317031 |
| Contact | Wang Minjun |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| 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 | 2021-09-23 |
| Decision Date | 2022-04-27 |