ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS
Device Facts
| Record ID | K871715 |
|---|---|
| Device Name | ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS |
| Applicant | Tambrands, Inc. |
| Product Code | HEB · Obstetrics/Gynecology |
| Decision Date | Jun 30, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5470 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.
