The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Surgical Light 22 Series.
| Device ID | K781581 |
| 510k Number | K781581 |
| Device Name: | SURGICAL LIGHT 22 SERIES |
| Classification | Lamp, Operating-room |
| Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQP |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-15 |
| Decision Date | 1978-10-17 |