510(k) K191666
K191666 is an FDA 510(k) premarket notification submitted by Ontex Bvba for the device "Unscented W long plastic and cardboard applicator tampons". The FDA issued a decision of Substantially Equivalent on December 20, 2019. The device falls under product code HEB (Tampon, Menstrual, Unscented), a Class II device regulated under 21 CFR 884.5470. Ontex Bvba has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2019
- Date Received
- June 21, 2019
- Clearance Type
- Traditional
- 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.