The following data is part of a premarket notification filed by Mooncup Llc with the FDA for Mooncup, Style A & B.
| Device ID | K040335 |
| 510k Number | K040335 |
| Device Name: | MOONCUP, STYLE A & B |
| Classification | Cup, Menstrual |
| Applicant | MOONCUP LLC ONE EAST MAIN STREET Madison, WI 53701 |
| Contact | Morris Waxler |
| Correspondent | Morris Waxler MOONCUP LLC ONE EAST MAIN STREET Madison, WI 53701 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-11 |
| Decision Date | 2005-03-30 |
| Summary: | summary |