The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Rhea Cup.
| Device ID | K112165 |
| 510k Number | K112165 |
| Device Name: | RHEA CUP |
| Classification | Cup, Menstrual |
| Applicant | APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Contact | Scott Herrick |
| Correspondent | Scott Herrick APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-28 |
| Decision Date | 2012-05-24 |
| Summary: | summary |