The following data is part of a premarket notification filed by Sol-millennium Medical Inc. with the FDA for Sol-m Luer Lock Syringe.
| Device ID | K222744 |
| 510k Number | K222744 |
| Device Name: | Sol-M Luer Lock Syringe |
| Classification | Syringe, Piston |
| Applicant | Sol-Millennium Medical Inc. 315 Shawnee North Dr. Suite 100 Suwanee, GA 30024 |
| Contact | Ying Zhao |
| Correspondent | Ying Zhao Sol-Millennium Medical Inc. 315 Shawnee North Dr. Suite 100 Suwanee, GA 30024 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-12 |
| Decision Date | 2022-10-11 |