The following data is part of a premarket notification filed by Shandong Weigao Group Medical Polymer Co., Ltd. with the FDA for Sterile Safety Syringe With Needle For Single Use, Sterile Safety Hypodermic Needle For Single Use,sterile Auto-disable Syringe With Needle For Single Use.
| Device ID | K212920 |
| 510k Number | K212920 |
| Device Name: | Sterile Safety Syringe With Needle For Single Use, Sterile Safety Hypodermic Needle For Single Use,Sterile Auto-Disable Syringe With Needle For Single Use |
| Classification | Syringe, Piston |
| Applicant | Shandong Weigao Group Medical Polymer Co., Ltd. No.18 Xingshan Road, Torch Hi-tech Science Park Weihai, CN 264210 |
| Contact | Lina Liu |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FMF |
| Subsequent Product Code | FMI |
| Subsequent Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-14 |
| Decision Date | 2022-03-11 |