The following data is part of a premarket notification filed by Lune Group Ltd. with the FDA for Lunette Menstrual Cup, Models 1 And 2.
| Device ID | K091754 |
| 510k Number | K091754 |
| Device Name: | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 |
| Classification | Cup, Menstrual |
| Applicant | LUNE GROUP LTD. 1920 ARLINGTON PLACE Madison, WI 53726 |
| Contact | Morris Waxler |
| Correspondent | Morris Waxler LUNE GROUP LTD. 1920 ARLINGTON PLACE Madison, WI 53726 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-11-13 |
| Summary: | summary |