The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Visum Surgical Lighting System.
| Device ID | K031068 |
| 510k Number | K031068 |
| Device Name: | STRYKER VISUM SURGICAL LIGHTING SYSTEM |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Melissa Murphy |
| Correspondent | Melissa Murphy Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-04 |
| Decision Date | 2003-08-12 |
| Summary: | summary |