The following data is part of a premarket notification filed by Lares Manufacturing Co., Inc. with the FDA for Fiber Optic Illuminator.
| Device ID | K801591 |
| 510k Number | K801591 |
| Device Name: | FIBER OPTIC ILLUMINATOR |
| Classification | Light, Fiber Optic, Dental |
| Applicant | LARES MANUFACTURING CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAY |
| CFR Regulation Number | 872.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-11 |
| Decision Date | 1980-07-21 |