The following data is part of a premarket notification filed by Gemtier Medical (shanghai) Inc. with the FDA for Sterile Syringe With Safety Needle For Single Use, Sterile Syringe For Single Use, Sterile Safety Needle For Single Use.
| Device ID | K192679 |
| 510k Number | K192679 |
| Device Name: | Sterile Syringe With Safety Needle For Single Use, Sterile Syringe For Single Use, Sterile 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 |
| 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 | 2019-09-26 |
| Decision Date | 2020-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G018SYS012501051 | K192679 | 000 |
| 16955356111447 | K192679 | 000 |
| 16955356111478 | K192679 | 000 |