BIOTEQUE VAGINAL DILATOR
Device Facts
| Record ID | K003380 |
|---|---|
| Device Name | BIOTEQUE VAGINAL DILATOR |
| Applicant | Bioteque America, Inc. |
| Product Code | HDX · Obstetrics/Gynecology |
| Decision Date | Jan 29, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.3900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.
