Clearance Summary
UNSCENTED MENSTRUAL TAMPON received FDA 510(k) clearance under submission number K941936, sponsored by Johnson & Johnson Worldwide. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1994-07-29.
- Submission: K941936
- Applicant / Sponsor: Johnson & Johnson Worldwide
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 1994-07-29
Classification & Regulation
This clearance is catalogued under FDA product code HEB and 21 CFR 884.5470, within the Obstetrics/Gynecology review panel as a Class II device.