The following data is part of a premarket notification filed by Shinva Ande Healthcare Apparatus Co., Ltd. with the FDA for Disposable Sterile Syringe With Permanently Attached Needle; Auto-disable Syringe For Fixed-dose Immunization.
| Device ID | K220057 |
| 510k Number | K220057 |
| Device Name: | Disposable Sterile Syringe With Permanently Attached Needle; Auto-disable Syringe For Fixed-dose Immunization |
| Classification | Syringe, Antistick |
| Applicant | Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road, Zibo, CN 255086 |
| Contact | Xiaolei Tian |
| 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 | 2022-01-06 |
| Decision Date | 2022-10-07 |