The following data is part of a premarket notification filed by Luneau Ophtalmologie Sa with the FDA for Ophthalmic Stand.
| Device ID | K913961 |
| 510k Number | K913961 |
| Device Name: | OPHTHALMIC STAND |
| Classification | Stand, Instrument, Ac-powered, Ophthalmic |
| Applicant | LUNEAU OPHTALMOLOGIE SA B.P. 252 Chartres, Cedex, FR 28005 |
| Contact | Young |
| Correspondent | Young LUNEAU OPHTALMOLOGIE SA B.P. 252 Chartres, Cedex, FR 28005 |
| Product Code | HMF |
| CFR Regulation Number | 886.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1991-12-04 |