The following data is part of a premarket notification filed by Ocujet, Llc with the FDA for Stericap Mini Needle.
| Device ID | K183016 |
| 510k Number | K183016 |
| Device Name: | SteriCap Mini Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | OcuJet, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine OcuJet, 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 | 2018-10-31 |
| Decision Date | 2019-05-07 |