The following data is part of a premarket notification filed by Steris Corporation with the FDA for Steris Deepsite Fiber Optic Surgical Light.
| Device ID | K003577 |
| 510k Number | K003577 |
| Device Name: | STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | STERIS Corporation 2720 GUNTER PARK EAST Montgomery, AL 36109 |
| Contact | Raymond Ursick |
| Correspondent | Raymond Ursick STERIS Corporation 2720 GUNTER PARK EAST Montgomery, AL 36109 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-01-29 |