The following data is part of a premarket notification filed by Ultimed Incorporated with the FDA for Ulticare Disposable Pen Needles.
| Device ID | K213407 |
| 510k Number | K213407 |
| Device Name: | UltiCare Disposable Pen Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | UltiMed Incorporated 350 Highway 7, Suite 100 Excelsior, MN 55331 |
| Contact | Paul Lewis |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-10-19 |
| Decision Date | 2021-12-16 |