The following data is part of a premarket notification filed by Video-medical Devices, Ltd. with the FDA for Opti-disc.
| Device ID | K820626 |
| 510k Number | K820626 |
| Device Name: | OPTI-DISC |
| Classification | Camera, Surgical And Accessories |
| Applicant | VIDEO-MEDICAL DEVICES, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQM |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-04-09 |