The following data is part of a premarket notification filed by Luneau Laboratories with the FDA for Lune Au Curettes.
| Device ID | K850068 |
| 510k Number | K850068 |
| Device Name: | LUNE AU CURETTES |
| Classification | Curette, Uterine |
| 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 | HCY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-08 |
| Decision Date | 1985-04-08 |