ONCE TM
Device Facts
| Record ID | K800162 |
|---|---|
| Device Name | ONCE TM |
| Applicant | G.D. Searle and Co. |
| Product Code | HDW · Obstetrics/Gynecology |
| Decision Date | Feb 11, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5350 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.
