510(k) K212304
K212304 is an FDA 510(k) premarket notification submitted by Calla Lily Personal Care, Ltd. for the device "Callaly Tampliner (super plus absorbency)". The FDA issued a decision of Substantially Equivalent on Aug 19, 2021. The device falls under product code HEB (Tampon, Menstrual, Unscented), a Class II device regulated under 21 CFR 884.5470. Calla Lily Personal Care, Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2021
- Date Received
- Jul 23, 2021
- 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
- 510(k)
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.