The following data is part of a premarket notification filed by Design Research Assoc., Inc. with the FDA for Biomicroscopy Contact Lens.
| Device ID | K813313 |
| 510k Number | K813313 |
| Device Name: | BIOMICROSCOPY CONTACT LENS |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | DESIGN RESEARCH ASSOC., INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-24 |
| Decision Date | 1982-03-01 |