The following data is part of a premarket notification filed by Amsco Co. with the FDA for Surgical Light.
| Device ID | K823360 |
| 510k Number | K823360 |
| Device Name: | SURGICAL LIGHT |
| Classification | Lamp, Surgical |
| Applicant | AMSCO CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-05 |
| Decision Date | 1982-12-03 |