The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Medtronic Solan Fiberoptic Corneal Light Probe.
| Device ID | K000728 |
| 510k Number | K000728 |
| Device Name: | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | David Timlin |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-03-06 |
| Decision Date | 2000-03-21 |