The following data is part of a premarket notification filed by Stryker Communications Corp. with the FDA for Visum Led Surgical Lighting System.
| Device ID | K060802 |
| 510k Number | K060802 |
| Device Name: | VISUM LED SURGICAL LIGHTING SYSTEM |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | STRYKER COMMUNICATIONS CORP. 1410 LAKESIDE PKWY., #100 Flower Mound, TX 75028 |
| Contact | Louis-pierre Marcoux |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-24 |
| Decision Date | 2006-04-07 |
| Summary: | summary |