The following data is part of a premarket notification filed by Woodlyn, Inc. with the FDA for Woodlyn Classic Exam. Chair.
| Device ID | K842045 |
| 510k Number | K842045 |
| Device Name: | WOODLYN CLASSIC EXAM. CHAIR |
| Classification | Chair, Ophthalmic, Ac-powered |
| Applicant | WOODLYN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HME |
| CFR Regulation Number | 886.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-21 |
| Decision Date | 1984-06-19 |