The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sure-snap Safety Needle, Medline Sure-snap Safety Syringe.
| Device ID | K213054 |
| 510k Number | K213054 |
| Device Name: | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe |
| Classification | Syringe, Piston |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Dinah Rincones |
| Correspondent | Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | FMF |
| Subsequent Product Code | FMI |
| Subsequent Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-12-09 |