The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hypodermic Needle-pro Edge Safety Device.
| Device ID | K211634 |
| 510k Number | K211634 |
| Device Name: | Hypodermic Needle-Pro EDGE Safety Device |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Dominique Neisz |
| Correspondent | Dominique Neisz Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | FMI |
| Subsequent Product Code | FMF |
| Subsequent Product Code | MEG |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-27 |
| Decision Date | 2021-08-26 |