The following data is part of a premarket notification filed by Ocuject, Llc with the FDA for Stericap Mini Needle And Standard Needles.
| Device ID | K212805 |
| 510k Number | K212805 |
| Device Name: | SteriCap Mini Needle And Standard Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-02 |
| Decision Date | 2021-09-30 |