The following data is part of a premarket notification filed by Rodenstock Instrument Corp. with the FDA for Lensometer Model 11.
| Device ID | K781440 |
| 510k Number | K781440 |
| Device Name: | LENSOMETER MODEL 11 |
| Classification | Instrument, Measuring, Lens, Ac-powered |
| Applicant | RODENSTOCK INSTRUMENT CORP. 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 | 1978-08-18 |
| Decision Date | 1978-09-07 |