The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Corneal Light Shield.
| Device ID | K850270 |
| 510k Number | K850270 |
| Device Name: | CORNEAL LIGHT SHIELD |
| Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Applicant | MENTOR O & O, INC. SOUTH SHORE PARK Hingham, MA 02043 |
| Contact | David M Link |
| Correspondent | David M Link MENTOR O & O, INC. SOUTH SHORE PARK Hingham, MA 02043 |
| Product Code | HRM |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-05-31 |