The following data is part of a premarket notification filed by Castle Co. with the FDA for 9100 Daystar And 9110 Orbiter Package.
| Device ID | K781887 |
| 510k Number | K781887 |
| Device Name: | 9100 DAYSTAR AND 9110 ORBITER PACKAGE |
| 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 | 1978-11-07 |
| Decision Date | 1978-12-12 |