The following data is part of a premarket notification filed by Astralite Corp. with the FDA for Floor Standing, Operating And Examining Light.
| Device ID | K893813 |
| 510k Number | K893813 |
| Device Name: | FLOOR STANDING, OPERATING AND EXAMINING LIGHT |
| Classification | Light, Surgical, Floor Standing |
| Applicant | ASTRALITE CORP. 6090-A ENTERPRISE DR. Diamond Springs, CA 95619 |
| Contact | Swartz |
| Correspondent | Swartz ASTRALITE CORP. 6090-A ENTERPRISE DR. Diamond Springs, CA 95619 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-23 |
| Decision Date | 1989-07-14 |