The following data is part of a premarket notification filed by Woodlyn, Inc. with the FDA for Woodlyn Classic Lensmeter.
| Device ID | K920861 |
| 510k Number | K920861 |
| Device Name: | WOODLYN CLASSIC LENSMETER |
| Classification | Instrument, Measuring, Lens, Ac-powered |
| Applicant | WOODLYN, INC. 2920 MALMO DR. Arlington Heights, IL 60005 -4726 |
| Contact | Ronald Nielson |
| Correspondent | Ronald Nielson WOODLYN, INC. 2920 MALMO DR. Arlington Heights, IL 60005 -4726 |
| Product Code | HLM |
| CFR Regulation Number | 886.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1992-07-30 |