The following data is part of a premarket notification filed by Luneau Laboratories with the FDA for Ophthalmic Chair.
| Device ID | K844362 |
| 510k Number | K844362 |
| Device Name: | OPHTHALMIC CHAIR |
| Classification | Stand, Instrument, Ac-powered, Ophthalmic |
| Applicant | LUNEAU LABORATORIES 2000 L. ST. NW SUITE 715 Washington, DC 20036 |
| Contact | Chambord |
| Correspondent | Chambord LUNEAU LABORATORIES 2000 L. ST. NW SUITE 715 Washington, DC 20036 |
| Product Code | HMF |
| CFR Regulation Number | 886.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1984-12-11 |