510(k) K132819
K132819 is an FDA 510(k) premarket notification submitted by Playtex Manufacturing, Inc. for the device "PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS". The FDA issued a decision of Substantially Equivalent on October 9, 2013. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Playtex Manufacturing, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2013
- Date Received
- September 9, 2013
- Clearance Type
- Special
- 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
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.