510(k) K152284
K152284 is an FDA 510(k) premarket notification submitted by Cotton High Tech S.L. for the device "COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS". The FDA issued a decision of Substantially Equivalent on December 4, 2015. The device falls under product code HEB (Tampon, Menstrual, Unscented), a Class II device regulated under 21 CFR 884.5470. Cotton High Tech S.L. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2015
- Date Received
- August 12, 2015
- 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.