The following data is part of a premarket notification filed by Woodlyn, Inc. with the FDA for Woodlyn Classic Keratometer.
| Device ID | K841767 |
| 510k Number | K841767 |
| Device Name: | WOODLYN CLASSIC KERATOMETER |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | WOODLYN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-27 |
| Decision Date | 1984-08-07 |