The following data is part of a premarket notification filed by Woodlyn, Inc. with the FDA for Woodlyn Classic Refractor, Phoroptor.
| Device ID | K874900 |
| 510k Number | K874900 |
| Device Name: | WOODLYN CLASSIC REFRACTOR, PHOROPTOR |
| Classification | Refractor, Manual, Non-powered, Including Phoropter |
| Applicant | WOODLYN, INC. 2920 MALMO DR. Arlington Heights, IL 60005 -4726 |
| Contact | Ronal Nielsen |
| Correspondent | Ronal Nielsen WOODLYN, INC. 2920 MALMO DR. Arlington Heights, IL 60005 -4726 |
| Product Code | HKN |
| CFR Regulation Number | 886.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-01 |
| Decision Date | 1987-12-23 |