The following data is part of a premarket notification filed by Castle Co. with the FDA for Daystar Surg. Light 9100 & Orbiter 9110.
| Device ID | K771865 |
| 510k Number | K771865 |
| Device Name: | DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | CASTLE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-03 |
| Decision Date | 1977-11-28 |