The following data is part of a premarket notification filed by Chirana T. Injecta with the FDA for Medoject Fine Pen Needles.
| Device ID | K220614 |
| 510k Number | K220614 |
| Device Name: | MEDOJECT Fine Pen Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Chirana T. Injecta Nám. Dr. Schweitzera 194 Stará Turá, SK 916 01 |
| Contact | Zdenka Klbeckova |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-06-15 |