The following data is part of a premarket notification filed by Alicia International Pty Ltd. with the FDA for Alicia Menstrual Cup.
| Device ID | K070965 |
| 510k Number | K070965 |
| Device Name: | ALICIA MENSTRUAL CUP |
| Classification | Cup, Menstrual |
| Applicant | ALICIA INTERNATIONAL PTY LTD. P.O. BOX 1471 Oxenford, Queensland, AU 4210 |
| Contact | Tom Stone |
| Correspondent | Tom Stone ALICIA INTERNATIONAL PTY LTD. P.O. BOX 1471 Oxenford, Queensland, AU 4210 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-05 |
| Decision Date | 2008-03-05 |
| Summary: | summary |