The following data is part of a premarket notification filed by Clement Clarke, Inc. with the FDA for Vision-stimulator, Cam.
| Device ID | K781313 |
| 510k Number | K781313 |
| Device Name: | VISION-STIMULATOR, CAM |
| Classification | Device, Fixation, Ac-powered, Ophthalmic |
| Applicant | CLEMENT CLARKE, INC. MD |
| Product Code | HPL |
| CFR Regulation Number | 886.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-31 |
| Decision Date | 1979-01-26 |