510(k) K011996
K011996 is an FDA 510(k) premarket notification submitted by Procter & Gamble Co. for the device "TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS". The FDA issued a decision of Substantially Equivalent on Sep 19, 2001. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Procter & Gamble Co. has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 19, 2001
- Date Received
- Jun 27, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tampon, Menstrual, Scented, Scented-Deodorized
- Device Class
- Class II
- Regulation Number
- 884.5460
- Review Panel
- OB
- Submission Type
- 510(k)
A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.