The following data is part of a premarket notification filed by Microvasive with the FDA for Hypodermic Needles & Stylets.
| Device ID | K840033 |
| 510k Number | K840033 |
| Device Name: | HYPODERMIC NEEDLES & STYLETS |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MICROVASIVE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-05 |
| Decision Date | 1984-04-05 |