The following data is part of a premarket notification filed by Mooncup Limited with the FDA for Mooncup.
| Device ID | K060852 |
| 510k Number | K060852 |
| Device Name: | MOONCUP |
| Classification | Cup, Menstrual |
| Applicant | MOONCUP LIMITED DOLPHIN HOUSE 40 ARUNDEL STREET Brighton, GB Bn2 1gd |
| Contact | Su Hardy |
| Correspondent | Su Hardy MOONCUP LIMITED DOLPHIN HOUSE 40 ARUNDEL STREET Brighton, GB Bn2 1gd |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-28 |
| Decision Date | 2006-12-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060053029996 | K060852 | 000 |
| 05060053028883 | K060852 | 000 |
| 05060053021129 | K060852 | 000 |
| 05060053022232 | K060852 | 000 |