The following data is part of a premarket notification filed by Azur Medical Company Inc. with the FDA for Sterile Auto-disable Syringes With/without Needle For Single Use.
| Device ID | K211210 |
| 510k Number | K211210 |
| Device Name: | Sterile Auto-Disable Syringes With/without Needle For Single Use |
| Classification | Syringe, Piston |
| Applicant | Azur Medical Company Inc. 6710 Everglades Dr. Richmond, VA 23838 |
| Contact | Di Zhao |
| Correspondent | Di Zhao Azur Medical Company Inc. 6710 Everglades Dr. Richmond, VA 23838 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2022-01-27 |