The following data is part of a premarket notification filed by Colmed, Ltd. with the FDA for Halogen Headlight System.
| Device ID | K810117 |
| 510k Number | K810117 |
| Device Name: | HALOGEN HEADLIGHT SYSTEM |
| Classification | Light, Surgical Headlight |
| Applicant | COLMED, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBA |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-16 |
| Decision Date | 1981-02-10 |