The following data is part of a premarket notification filed by Ocuject, Llc with the FDA for Miniload Syringe.
| Device ID | K202432 |
| 510k Number | K202432 |
| Device Name: | MiniLoad Syringe |
| Classification | Syringe, Piston |
| Applicant | OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-25 |
| Decision Date | 2021-02-19 |