510(k) K897012
K897012 is an FDA 510(k) premarket notification submitted by Playtex Family Products, Inc. for the device "SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS". The FDA issued a decision of Substantially Equivalent on Dec 22, 1989. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Playtex Family Products, Inc. has 16 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 1989
- Date Received
- Dec 20, 1989
- 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.