The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Hyposermic Needles.
| Device ID | K813545 |
| 510k Number | K813545 |
| Device Name: | HYPOSERMIC NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | OPTICAL MICRO SYSTEMS, INC. 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 | 1981-12-21 |
| Decision Date | 1982-01-12 |