The following data is part of a premarket notification filed by Designs For Vision, Inc. with the FDA for Illuminated Speculum.
| Device ID | K801058 |
| 510k Number | K801058 |
| Device Name: | ILLUMINATED SPECULUM |
| Classification | Speculum, Illuminated |
| Applicant | DESIGNS FOR VISION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXF |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-06 |
| Decision Date | 1980-05-28 |