The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Magnifying Spectacles.
| Device ID | K844038 |
| 510k Number | K844038 |
| Device Name: | VISITEC MAGNIFYING SPECTACLES |
| Classification | Spectacle, Magnifying |
| Applicant | VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Contact | Eugene H Beckstein |
| Correspondent | Eugene H Beckstein VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Product Code | HOI |
| CFR Regulation Number | 886.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-16 |
| Decision Date | 1984-11-29 |