The following data is part of a premarket notification filed by Smr with the FDA for Dimension I Refraction System.
| Device ID | K801767 |
| 510k Number | K801767 |
| Device Name: | DIMENSION I REFRACTION SYSTEM |
| Classification | Instrument, Measuring, Lens, Ac-powered |
| Applicant | SMR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLM |
| CFR Regulation Number | 886.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-09-16 |