The following data is part of a premarket notification filed by Stryker Communications with the FDA for Visum Blade Led Surgical Lighting System.
| Device ID | K132747 |
| 510k Number | K132747 |
| Device Name: | VISUM BLADE LED SURGICAL LIGHTING SYSTEM |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | STRYKER COMMUNICATIONS 1410 LAKESIDE PKWY., #100 Flower Mound, TX 75028 |
| Contact | Trey Thorsen |
| Correspondent | Trey Thorsen STRYKER COMMUNICATIONS 1410 LAKESIDE PKWY., #100 Flower Mound, TX 75028 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2013-12-30 |
| Summary: | summary |