The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Universal Trial Framee.
| Device ID | K821084 |
| 510k Number | K821084 |
| Device Name: | UNIVERSAL TRIAL FRAMEE |
| Classification | Frame, Trial, Ophthalmic |
| Applicant | MEDICAL EQUIPMENT DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPA |
| CFR Regulation Number | 886.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-19 |
| Decision Date | 1982-06-14 |