510(k) K113036
K113036 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corporation for the device "U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS". The FDA issued a decision of Substantially Equivalent on November 2, 2011. The device falls under product code HEB (Tampon, Menstrual, Unscented), a Class II device regulated under 21 CFR 884.5470. Kimberly-Clark Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2011
- Date Received
- October 12, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tampon, Menstrual, Unscented
- Device Class
- Class II
- Regulation Number
- 884.5470
- Review Panel
- OB
- Submission Type
An unscented 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.