MAC LEE VAGINAL IRRIGATOR
Device Facts
| Record ID | K841710 |
|---|---|
| Device Name | MAC LEE VAGINAL IRRIGATOR |
| Applicant | Mac Lee Medical Products |
| Product Code | HED · Obstetrics/Gynecology |
| Decision Date | Jun 19, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.
