The following data is part of a premarket notification filed by Gemtier Medical (shanghai) Inc. with the FDA for Sterile Syringe With Fixed Safety Needle For Single Use.
| Device ID | K212652 |
| 510k Number | K212652 |
| Device Name: | Sterile Syringe With Fixed Safety Needle For Single Use |
| Classification | Syringe, Antistick |
| Applicant | Gemtier Medical (Shanghai) Inc. No.18 Jianding Road, Fengjing Town, Jinshan District Shanghai, CN 201502 |
| Contact | Lenny Cao |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2022-03-02 |