TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
Device Facts
| Record ID | K002096 |
|---|---|
| Device Name | TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR |
| Applicant | Procter & Gamble Co. |
| Product Code | HEB · Obstetrics/Gynecology |
| Decision Date | Sep 8, 2000 |
| 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.
