UNI-SEM(TM)
Device Facts
| Record ID | K910317 |
|---|---|
| Device Name | UNI-SEM(TM) |
| Applicant | Unimar, Inc. |
| Product Code | MFD · Obstetrics/Gynecology |
| Decision Date | May 1, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.