The following data is part of a premarket notification filed by Schott North America with the FDA for Light Guide Cable.
| Device ID | K111342 |
| 510k Number | K111342 |
| Device Name: | LIGHT GUIDE CABLE |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | SCHOTT NORTH AMERICA 40 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Jeffrey Roberts |
| Correspondent | Jeffrey Roberts SCHOTT NORTH AMERICA 40 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-11-25 |
| Summary: | summary |